StudyFinder

Search Results Within Category "Cancer"

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

Search all categories
116 Study Matches

Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age

This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .

This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .

Yes
 

Seema Naik
CI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03834688
STUDY00013967
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL)
Must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension
ECOG performance status of 0-2
Adequate organ function as measured by the criteria
Total Bilirubin ≤ 1.5x upper limit of normal (ULN) or ≤ 3x ULN with documented Gilbert’s syndrome

Exclusion Criteria:
Should not have known evidence of central nervous system (CNS) lymphoma
Should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma
Must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication
Must have no active, uncontrolled infections
Must not have active hepatitis B or be chronic carriers of hepatitis B.
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004) (PSCI# 20-136)

The purpose of this study is to compare the usual treatment plus placebo to the usual treatment plus atezolizumab. The addition of atezolizumab to the usual treatment could stabilize your cancer. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the atezolizumab lengthens the time during and after the treatment of your cancer that you live with your cancer and it is stable. Atezolizumab is already approved by the FDA for use in non-small cell lung cancer and urinary cancer. Its use in this study is considered experimental. There will be about 600 people taking part in this study.

pt will initially get the chemotherapy drug paclitaxel or docetaxel along with trastuzumab, pertuzumab, and either placebo or atezolizumab.

Yes
 

Monali Vasekar
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03199885
SITE00000916
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Patient must have an ECOG Performance Status of 0 or 1
Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease, or metastatic disease
Adequate hematologic function within 14 days prior to randomization
Localized palliative radiation therapy is allowed for symptom management if completed 14 days or more prior to randomization
Adequate renal function determined within 14 days prior to randomization

Exclusion Criteria:
Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded
History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body surface area or its equivalent
Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including antiCD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.

For the treatment arm of this study you will no receive the total body radiation (TBI) as typically given before transplant. In this study you will have various research procedures such as a Blast sample at the screening part of the study, and MRD testing of your bone marrow and blood at screening and through the course of the study. Participation in the treatment arm (Non-TBI) of the study will last up to 5 years.

Yes
 

Robert Greiner
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT01656603
STUDY00015052
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
You have a disorder affecting your hematopoietic system (the organs and tissues that produce your blood) that is inherited, acquired, or from previous chemotherapy

Exclusion Criteria:
You are receiving licensed cord blood products
You are receiving unlicensed CB products from other CB banks
Blood Disorders, Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Parallel Phase III Randomized Trials For High Risk Prostate Cancer Evaluating De-Intensification For Lower Genomic Risk and Intensification for Higher Genomic Risk with Radiation (NRG-GU009) (PSCI# 20-141)

This study is being done to answer the following questions: If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment? If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cancer.

This study is being done to answer the following questions:If you have high risk prostate cancer, a low gene risk score and plan to receive radiation therapy, is a shorter hormone therapy treatment as effective at controlling your cancer compared to the usual 24 month hormone therapy treatment?If you have high risk prostate cancer, a high gene risk score and plan to receive radiation therapy, does adding two new hormone therapy drugs to the usual treatment increase the length of time without your prostate cancer spreading as compared to the usual treatment?We are doing this study because we want to find out if these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cance

Yes
 

Joseph Miccio
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04513717
SITE00000914
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days
High-risk disease
ECOG Performance Status of 0-2 within 120 days prior to registration
Adequate hematologic function within 120 days prior to registration
Adequate hepatic function within 120 days prior to registration

Exclusion Criteria:
Prior radical prostatectomy
Prior systemic chemotherapy within ≤3 years prior to registration
Current use of 5-alpha reductase inhibitor
Didanosine (DDI) antiretroviral therapy is not permitted
History of seizure disorder or current severe or unstable angina
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer (PSCI# 21-217) (NRG-GU010)

The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness. The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score. If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.

The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness.The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score.If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.

Yes
 

Joseph Miccio
psci-cto@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05050084
SITE00001119
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Age ≥ 18
ECOG Performance Status of 0-2 within 120 days prior to registration;
For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease
Previous bilateral orchiectomy
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
Inability to swallow oral pills.
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study

Briefly, the purpose of this study is to use a self-management approach (combining education and exercise) to help older breast cancer survivors manage joint pain, a common side effect of aromatase inhibitors (AIs), a medication used to reduce hormones that might increase risk of recurrence and mortality following primary cancer treatment. We believe that reducing joint pain might help survivors take their medication longer and thus improve survival outcomes, compared to standard care.

Attend 4 in person visits, blood will be drawn at each visit.Complete physical function tests and surveys.Wear accelerometer for 7 days following each visit.Randomly selected participants will attend group exercise sessions twice a week for eight weeks via video call and record exercise activities between visits.

$160

Yes
 

Nancy Olsen
Nancy Olsen - at nolsen@pennstatehealth.psu.edu
Medicine: Rheumatology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03955627
STUDY00010776
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Age 60 and older
Female
Breast Cancer Survivor
Preparing to Start AI medication
ER+ diagnosis

Exclusion Criteria:
Already taking AI medication (greater than 24 weeks)
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

TMIST_EA1151

This study is being done to answer the following question:Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast?We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers.

Yes
 

Rebecca Sivarajah
Swati Shah - at sshah@pennstatehealth.psu.edu
Radiology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT03233191
SITE00000587
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Women age 45 or older and under age 75 at the time of study entry
Patients must be scheduled for, or have intent to schedule, a screening mammogram.
Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent.

Exclusion Criteria:
Women of childbearing potential must not be known to be pregnant or lactating.
Patients must not have new symptoms or signs of benign or malignant breast disease
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections).
Prevention, Cancer, Women's Health
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

CCTG MA.39- A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Purpose of this study is to compare any good and bad effects of not using regional radiotherapy to using radiotherapy. The study will help researcher learn if not giving regional radiotherapy is just as good as using regional therapy to treat node positive breast cancer in women.

Blood will be drawn at two time points and number of visits will be determined by the individual radiation treatment plan.

Yes
 

Marc Rovito
Michelle Eschbach - at meschbach@pennstatehealth.psu.edu or 610-378-2336
Cancer Institute (ST. JOSEPH)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03488693
AFFILCCTGMA39
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Estrogen Receptor Positive / Her2 Negative Breast Cancer
No evidence of metastasis
1 - 3 positive lymph nodes
May have had breast conserving surgery or mastectomy
35 years of age or older

Exclusion Criteria:
Nodal disease limited to micromets or isolated cells
History of ipsilateral breast cancer or DCIS
Synchronous or contralateral breast cancer
pT4 disease
Neoadjuvant Chemotherapy for breast cancer
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Reading, PA ,

A Phase II Pilot Trial to Estimate Survival After a Non-Total Body Irradiation (TBI) Based Conditioning Regimen in Patients Diagnosed with B-Acute Lymphoblastic Leukemia (ALL) Who Are Pre-Allogeneic Hematopoietic Cell Transplantation (HCT) Next-Generation-Sequence (NGS) Minimal Residual Disease (MRD) Negative

A study of the safety and efficacy of removing the total body irradiation part of the treatment of pediatric patients with B-ALL who are negative before their transplant to a sensitive sequencing test which measures minimal residual disease.

•Bone marrow and blood tests: for about a year extra bone marrow and blood will be collected for the disease NGS-MRD (next-generation-sequence minimal residual disease) testing to detect if you have any leukemia.•Let the research team record information from your medical record related to your condition and the treatment you receive.•If your NGS-MRD testing before your transplant shows that you are eligible for the Non-TBI (Total Body Irradiation) Arm of the study, it will be explained to you in a different consent form.

Yes
 

Robert Greiner
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT03509961
STUDY00021337
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Age 1 to 25 years at the time of screening
Diagnosis of High Risk B-ALL (Acute Lymphoblastic Leukemia) in CR1 (complete remission) after first-line treatment

Exclusion Criteria:
Bone Marrow blast count is above the required range
Philadelphia chromosome positive (Ph+) ALL (Acute Lymphoblastic Leukemia)
Prior tyrosine kinase inhibitor therapy
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A082002 Randomized Phase II/III of immunotherapy with or without SBRT PD-L1 negative NSCLC (22-026)

To assess if SBRT improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage NSCLC patients with PD-L1 TPS &lt;1% who receive immunotherapy with or without chemotherapy

We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

Yes
 

Joseph Miccio
psci-cto@pennstatehealth.psu.edu 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04929041
SITE00001209
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Age ≥ 18 years
No prior systemic chemotherapy or immunotherapy for advanced NSCLC
Not pregnant and not nursing
No known history of Hepatitis B or Hepatitis C
Platelet Count ≥ 100,000/mm3

Exclusion Criteria:
Live vaccine within 30 days prior to registration
Current pneumonitis or history of non-infectious pneumonitis that required steroids
Prior allogeneic tissue/solid organ transplant.
Age < 18 years
ECOG Performance Status over 3
Cancer
Not applicable
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

(NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB (PSCI# 19-109) (A031704)

The purpose of this study is to compare the usual treatment of advanced kidney cancer (treatment with ipilimumab and nivolumab followed by nivolumab alone) to the usual treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if adding cabozantinib to nivolumab can increase the percentage of patients alive at 3 years from 60% to 70%.

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.We are asking you to take part in this research study because you have advanced or metastatic kidney cancer.

Yes
 

Monika Joshi
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03793166
SITE00000692
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Histologic documentation of renal cell carcinoma with clear cell component
Age ≥ 18 years
Karnofsky performance status greater than or equal to 70%
Hemoglobin ≥8 g/dL
Platelet Count ≥ 100,000/mm3

Exclusion Criteria:
No prior previous systemic therapy for renal cell carcinoma.
No cancer therapy less than 28 days prior to registration; this includes radiation therapy.
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
No history of HIV or active hepatitis B/C, or tuberculosis
No uncontrolled hypertension (systolic BP >150mmHg or diastolic BP
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

PSCI 21-026 A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for CisplatinUndergoing Radical Cystectomy for Muscle Invasive Bladder Cancer(VOLGA)

A clinical trial for adults with Muscle Invasive Bladder Cancer. The study is looking at alternative treatments for those persons who cannot tolerate certain forms of chemotherapy.

This protocol contains two portions. The safety run in (SRI) and the main portion of the trial. The SRI will take place over three cycles of treatment prior to having cystectomy or 9 cycles if you have had a previous cystectomy. The main study will have the same schedule of activities. The only difference between the two is the SRI will look at how safe the drug combinations are and the main trial will look at how effective they are on treating muscle invasive bladder cancer.,

Yes
 

Monika Joshi
CI-CTO at psci-cto@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04960709
STUDY00018157
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Bladder Cancer
body weight above 30kg/66 pounds

Exclusion Criteria:
Metastatic disease
history or an organ transplant
inflammatory bowel disease
Cancer
Approved drug(s)
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)

This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.

venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax

Yes
 

Joseph Cioccio
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03504644
SITE00000009
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy(≥ 5% marrow lymphoblasts, assessed by morphology and flow cytometry
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent

Exclusion Criteria:
Pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (PSCI# 21-115) (EAA173).

The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups.Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma. It is not, however, approved for treatment of smoldering multiple myeloma, either alone or when combined with the treatment regimen of lenalidomide and dexamethasone, and therefore is considered experimental. Lenalidomide and dexamethasone are approved for treatment of multiple myeloma (symptomatic) but not for the treatment of smoldering multiple myeloma and therefore is also considered an experimental treatment.

We are asking you to take part in a research study because you have high-risk smoldering multiple myeloma. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

Yes
 

Seema Naik
psci-CTO@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03937635
SITE00001112
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Patient must be 18 years or older.
Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months.
A bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
Patient must have adequate organ and marrow function.
Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.

Exclusion Criteria:
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal or known moderate or severe persistent asthma within 2 years prior to randomization.
Concurrent use of erythropoietin is not allowed while on study therapy.
Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
Patients with monoclonal gammopathy of undetermined significance are not eligible.
Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

20-034, Phase 2 Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin with Previously Treated c-Met+ NSCLC

This study is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ non-small cell lung cancer.

Medical/Oncology history – questions will be asked regarding your health problems,details of your lung cancer diagnosis and previous treatment and questions regardingtobacco and alcohol use.• Physical exam• Vital signs – (check your blood pressure, heart rate, and temperature), weight, andheight.• Blood and urine tests to monitor your health:o Routine blood tests (approximately 2.5 teaspoons or 12.5 mL of blood) to checkyour blood counts (numbers of each type of blood cell), chemistries (elementsand minerals in your blood), blood clotting, testosterone and sex hormonebinding globulin (males only) and how well your organs are functioning.o Routine urine tests• Pregnancy Test (only for females who are able to get pregnant – done on the blood tubecollected for routine blood tests) - For post-menopausal women less than 55 years old, aserum pregnancy test including FSH levels (a hormone) will be collected at screening.o If confirmed post-menopausal, no additional pregnancy testing is required.o The study doctor or study staff will tell you if the pregnancy test results arepositive.o The results of the pregnancy testing must be negative in order for you to be inthe study.• Electrocardiogram (ECG) - an ECG measures the electrical activity of your heart.• Review of any medications you are taking – questions will be asked about anyprescribed and over the counter medications/supplements that you are taking.• Evaluate your performance status (your ability to perform daily activities) - your studydoctor will assess and assign a score based on your ability to perform daily tasks byasking questions.• Computed Tomography (CT)/ Magnetic Resonance Imaging (MRI) Scan – A CT scan ofthe full chest and abdomen is the preferred way of measuring your cancer (it may includeneck and pelvis, when clinically required). A CT scan uses radiation (x-rays) to makepictures of the inside of your body. The scan can show more details or even larger areasto show organs and structures in 3 dimensions (“3-D”).o The study doctor or study staff may give you a contrast dye, either by mouth orwith a needle. The study doctor or study staff can tell you more about thecontrast dye.• MRI scan – If you are unable to undergo CT scan your study doctor may have a MRIscan taken instead. For most people, there is no danger associated with having a MRIscan. However, a MRI could be very dangerous if you have certain objects or devices(usually metal) implanted in your body, such as a pacemaker, insulin pump, ear implant,joint replacement, surgical clips, permanent dentures, piercings, or shrapnel.o You must tell the study doctor or study staff about any objects that you know areimplanted or embedded in your body. Some people may feel claustrophobic, sotell the study staff if you are claustrophobic.• Magnetic Resonance Imaging (MRI) Scan of your brain – A Computed Tomography (CT)scan with contrast may be done if an MRI scan is contraindicated. If you have had anMRI/CT scan done recently as part of your regular medical care, an additional scan maynot be needed.• Tumor Material – If you qualify for participation in the study based on c-Met positivestatus, additional tumor material may have to be obtained during the Screening period inorder to participate in the study. Your study doctor will discuss the details with you.

Yes
 

Patrick Ma
psci-cto@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03539536
SITE00000765
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Adult male or female, at least 18 years old
Subjects must have c-Met+ NSCLC as assessed by an AbbVie designated IHC laboratory or known documented MET gene amplification
Subjects have adequate bone marrow, renal, and hepatic function
Subjects are willing and able to comply with procedures required in this protocol
Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:
Subjects must not have a history of major immunologic reaction to any IgG containing agent
Subjects must not have psychiatric illness/social situation that would limit compliance with the study
Subjects must not have any medical condition which in the opinion of the Investigator or Therapeutic Area Medical Director (TA MD) places the subject at an unacceptably high risk for toxicities
Subjects must not have received any live vaccine within 30 days of the first dose of investigational product
Subjects must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma

This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.

Phase II*propranolol twice a day.*pembrolizumab by an infusion every 3 weeks.*May receive treatment with pembrolizumab and propranolol for up to24 months from the time they began treatment with the combination.Procedures to be done:. A medical history  A physical exam ECOG Performance Status Perceived Stress Scale questionnaire An assessment of tumor by scan. Scans may include:o Computed tomography (CT), with or without contrast. o Magnetic resonance imaging (MRI) or head CT with IV contrast  Blood tests:o Approximately 2 tablespoons for routine testing, such as a complete blood count and acomprehensive metabolic panel Pregnancy test Urinalysis Electrocardiogram A sample of tumor from a previous biopsy or sample taken Phase 1 portion of the study, these evaluations/tests will also occur on Day 8 of Cycle 1 Review concomitant medications. Physical Exams ECOG Performance Status Perceived Stress Scale questionnaire Blood tests:o Every 3 weekso At 3 weeks and 6 months or discontinuation of treatment (whichever comes sooner) and atdisease progressiono Every 3 weeks: Approximately 1 tablespoon for tests that monitor your blood sugar levelsand thyroid functiono Every week for the first 6 weeks then every cycle for another 6 weeks Assessment of cancer by CT or MRI. These assessments will be performed every 12 weeks(± 14 days). The first assessment will be after completing Cycle 4. If their cancer is found to be improving,repeat the CT and MRI scans in about 12 weeks. EKG: Once treatment begins, this will be done every cycle prior to receiving pembrolizumab for the first 5 cycles. Adverse events Tumor Biopsy: A tumor biopsy (only in phase II) will be obtained at the 12 weeks after initiation oftreatment.Tumor biopsy will be optional for phase II patients..Safety Follow-Up:After all study treatment has stopped, end of treatmentvisit, which will be approximately 30 days after their last dose of study drug or before starting a newtreatment Medical History:  Concomitant medications complete physical examination ECOG Performance Status Perceived Stress Scale assessment Adverse events Survival status Blood tests:o Follow- Up Phase3 Month and 6 Month Follow- up After Treatment blood collected.The following assessments will be performed at 3 months and 6 months after the safety follow-up visit.Review concomitant medications Physical examination ECOG Performance Status Adverse events Survival Status Blood tests: CT of chest, abdomen and pelvis, or other areas as needed Long Term Survival Follow- Up:After your 3 month and 6 month follow up visits or if they progress, will be contacted every 6 months (±30 days)

Yes
 

Joseph Drabick
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03384836
STUDY00010009
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Age >=18 years.
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1

Exclusion Criteria:
Participants who have received previous immunotherapy for any cancer (excluding melanoma) including PD-1/PD-L1 inhibitors but not interferons and CTLA-4 inhibitors.
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03258554
SITE00000527
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
squamous cell carcinoma
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function

Exclusion Criteria:
invasive malignancy within the past 3 years
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER (PSCI# 20-133) (GO42784)

The purpose of this study is to compare the effects, good or bad, of giredestrant versus an approved endocrine therapy (a treatment that blocks or removes hormones), on patients with breast cancer. In this study, subjects will get either giredestrant or a drug chosen specifically by the study doctor. Subjects can participate in this study based on breast cancer characteristics, current condition, and how well previous anti-cancer therapies were tolerated.

• You should not join another research study.• For women: If you can become pregnant, you must use a reliable non-hormonal birth control method during the study and for 9 days after your final dose of giredestrant or, if you are in the group receiving approved endocrine therapy prescribed by the study doctor, a period of time that your study doctor will discuss with you. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 60 days after if you are prescribed tamoxifen. Talk with your study doctor about what birth control method may be best for you. Depending on the study treatment you receive, you might be restricted from donating eggs during this same period. Tell your study doctor right away if you get pregnant during this period. If you get pregnant, the study doctor will want to follow up with you on the outcome of the pregnancy and collect information on the baby.• For men: you must agree to take precautions as outlined below for each treatment arm:–If you are in the group receiving approved endocrine therapy prescribed by the study doctor, you study doctor will discuss with you what precautions you will need to take.–If you are in the group receiving giredestrant, and your partner is pregnant or able to become pregnant, you must use a condom during the study and for 9 days after your final dose of giredestrant. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 90 days after if you are prescribed tamoxifen. You must not donate sperm during this same period. Tell your study doctor right away if your partner becomes pregnant during these periods. The study doctor or research staff will advise you of the possible risks to your unborn child and will make an effort to contact your partner to get her permission to collect information about the pregnancy and the baby. No matter what your partner decides, you can continue to take part in this study.• You should not use certain medications during this study. Your study doctor will talk to you about these medications.

Yes
 

Monali Vasekar
Kelly Hansard - at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5317
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04961996
STUDY00019397
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Participants (females, regardless of menopausal status, and males) who are age  18 years at the time of signing the Informed Consent Form
Participants who have documented ER+ tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as  1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines
Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
Participants must have undergone definitive surgery of the primary breast tumor(s)
Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization

Exclusion Criteria:
Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC
Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research
Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
Participants who have active cardiac disease or history of cardiac dysfunction
Participants who have been diagnosed with Stage IV breast cancer
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Strengths, Outcomes, Adversity, and Resilience in College-Aged Childhood Cancer Survivors: The PSU SOAR Study

The purpose of this study is to analyze the strengths, outcomes, adversity, and resilience, as indicated by self-reported experiences in college students who may or may not be childhood cancer survivors. We are asking college students aged 18-23 years attending 4 year universities in the United States to report on their childhood health experiences and their current mental, physical, and social well being during college using a confidential survey. We plan to recruit students who have or have not had a childhood history of cancer and will also ask questions about their demographic information and health habits.

The participants will be asked to complete a confidential online survey that will take 10-15 minutes to complete.

Participants are eligible to earn a $75 Amazon gift card through a random drawing that they can choose to enter after submitting their survey responses

No
 

Laura Klein
Nikolette Nolte - at nmn5225@psu.edu or 484-268-6550
Biobehavioral Health (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019071
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Aged 18-23 years
College student attending 4 year university
English as primary language

Exclusion Criteria:
Younger than 18 years or older than 23 years
Not attending a 4 year university
Does not have English as primary language
Mental & Behavioral Health, Cancer
Not applicable
I'm interested
Share via email

Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (PSCI# 21-207) (NRG-HN009)

The purpose of this study is to compare two usual treatment approaches to your head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks. The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach. There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.

he first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks.The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach.There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.

Yes
 

Sean Mahase
PSCI-CTO@pennstatehealth.psu.edu
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05050162
SITE00001120
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to registration
Age ≥ 18
Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration
Adequate hematologic function within 30 days prior to registration
Adequate renal function within 30 days prior to registration defined as calculated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault formula

Exclusion Criteria:
Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP);
Definitive clinical or radiologic evidence of distant metastatic disease
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Pregnancy and individuals unwilling to discontinue nursing
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor (PSCI# 21-039)

The purpose of the dose-escalation part is to evaluate GEN1046 in subjects with solid malignant tumors to determine the maximum tolerated dose (MTD) or maximum administered dose and/or the recommended phase 2 dose (RP2D). The purpose of the expansion part is the further evaluate the safety, tolerability, PK and antitumor activity of the selected dose(s) in select solid tumors.

The participants will be required to follow the trial doctor's instructions, have tests and checks done as part of the trial, inform the trial doctor of any changes in how they are feeling, be open and honest about their health history, inform the study team of all concomitant medications, and inform the trial doctor if you decide not to participate in the trial anymore.

Yes
 

Patrick Ma
psci-cto@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05117242
STUDY00019590
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Subject must be at least 18 years of age
Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 monoclonal antibody (mAb)
Subject must have tumor PD-L1 expression of tumor proportion score (TPS) >= 1%
Subject must have measurable disease per RECIST v1.1
Subject must have Eastern Cooperative Oncology Group (ECOG) PS <= 1

Exclusion Criteria:
Subject has documentation of known EGFR, ROS1 or ALK mutations or gene rearrangements
Subject has been exposed to prior treatment with docetaxel for NSCLC
Subject has been exposed to prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine or autologous cell immunotherapy
Subject has been exposed to treatment with an anti-cancer agent within 28 days prior to GEN1046 administration
Subject discontinued treatment due to disease progression within the first 6 weeks of a CPI-containing treatment
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

EA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial (PSCI# 21-111)

The purpose of this study is to compare the usual treatment (surgery plus chemotherapy after) to using chemotherapy both before and after surgery. Receiving gemcitabine/cisplatin chemotherapy both before and after surgery could extend your life and prevent your cancer from returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will look to see if the chemotherapy increases the time to disease recurrence and if it increases a patient’s overall survival compared to the usual approach given both before and after surgery.

We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. We are asking you to take part in this research study because you have recently been diagnosed with gallbladder cancer that was found after your gallbladder was removed during surgery.

Yes
 

Rushin Brahmbhatt
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Surgery: General Surgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04559139
SITE00001045
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Patient must be = 18 years of age.
Patient must have an ECOG performance status of 0-1.
Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization
Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease

Exclusion Criteria:
Patient must not have any evidence of metastatic disease or inoperable loco-regional disease based on high-quality, preoperative, cross-sectional imaging (CT or MRI) of the chest, abdomen, and pelvis (C/A/P) obtained within 6 weeks prior to randomization
Women must not be pregnant or breast feeding due to the potential harm to unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
No radiographic evidence of distant disease (M1 disease)
No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease)
No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes)
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Examining brain responses linked to emotion in individuals who smoke cigarettes

The goal of this study is to measure emotional and brain responses related to the motivation to smoke cigarettes. The study uses a method called functional magnetic resonance imaging, or fMRI, which is a research method for measuring activity in the brain. The study also involves measuring moment-to-moment changes in emotion by coding facial expressions. A primary goal of the project is to examine how changes in brain activity are related to changes in emotion over time. If successful, the project will help to demonstrate the usefulness of combining fMRI and facial coding to study cigarette smoking and other harmful behaviors.

There will be two in-person visits. Brain imaging scans (using functional magnetic resonance imaging) will be completed at one of these visits.

100

Yes
 

Stephen Wilson
Stephen Wilson - at sjw42@psu.edu
Psychology (UNIVERSITY PARK)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT04310735
STUDY00011266
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Between 21 and 55 years old
Must smoke cigarettes each day
Must be right handed
Must be fluent English speaker
Must be willing to abstain from smoking for 12 hours during the study

Exclusion Criteria:
Must not be actively trying to quit smoking
Must not currently have significant cardiovascular or respiratory disease
Must not be claustrophobic
Smoking, Vaping, Nicotine and Tobacco, Addiction & Substance Abuse, Cancer
Not applicable
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
State College, PA ,

A Phase Ib/II Study of APG-115 as a Monotherapy or in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors

Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors.Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas. To assess APG-115 as a monotherapy in patients with unresectable or metastatic melanomas and MPNST cohorts only.

If you are eligible and agree to receive the study drug combination, you will need to come to the study site at various times to have procedures done. These procedures may include collection of vital signs, blood andurine samples, electrocardiogram, physical exam, tumor biopsy, imagingscans, and x-ray. At each visit, you will be asked about your current medicines, including over-the-counter medications, and about any symptoms or side effects you might be having. You will receive the study drug orally on Days 1, 3, 5, 7, 9, 11, 13 of every 21-day cycle. Pembrolizumab is given as a 30-minute intravenous (IV – through a needle into a vein) infusion on Day 1 of every 21-day cycle.

Yes
 

Joseph Drabick
Irina Geier - at igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03611868
STUDY00014555
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent
Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy
ECOG Performance scale of 0-2
Life expectancy of equal to or greater than 3 months
Adequate bone marrow and organ functionAdequate

Exclusion Criteria:
Any prior systemic MDM2-p53 inhibitor treatment Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to first dose.
Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment.
Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose.
Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS.
Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

PSCI 21-038 Phase Ib Study of Brigatinib Plus Bevacizumab in Patients with ALK-rearranged Non-Small Cell Lung Cancer (NSCLC)

Clinical trial on the treatment of persons who are diagnosed with Lung Cancer.

Participants in this study will undergo screening tests and procedures to determine whether you are eligible to participate with the research study. If you meet the requirements to participate with the study, you be given Brigatinib by mouth each day for 7 days. If you do not experience any intolerable side effects while taking Brigatinib, you will receive an increased dose starting on Day 8 and take Brigatinib continuously each day thereafter. Bevacizumab will be given intravenously (IV) on Day 8 in combination with Brigatinib. The first 28 days of treatment is called Cycle 1. Starting Cycle 2 and thereafter, one cycle will consist of 21 days. Bevacizumab will be given on Day 1 every 21 days starting Cycle 2. Participation is expected to last until your disease worsens or you decide you no longer want to participate in the study. There will be a follow-up visit within 30 days of treatment discontinuation. The study team will check in with you every three months after this final visit to see how you are doing.If you decide to take part, this is what will happen: Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have Anaplastic Lymphoma Kinase (ALK) Rearranged Non-Small Cell Lung Cancer (NSCLS), not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. If you take part in this research study, you will be given a drug diary. You will be asked to document information in the drug diary about the study drug you are being asked to take.If you take part in this research, study you will be given a study calendar. Information about what to expect during and between study visits will be included in the study calendar.

Yes
 

Patrick Ma
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04227028
STUDY00018451
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
lung cancer

Exclusion Criteria:
other cancer in the last 3 years
major surgery in the last 30 days
heart attack or stroke in the last 6 months
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

PSCI 22-082 Tropion-Breast03

This is an investigational drug study comparing the Investigational treatment with treatments called capecitabine and pembrolizumab as stand-alone treatment agents or in combination. Study participants will be required to attend all study visits, complete the tests and procedures, receive study treatment, and complete questionnaires.

Participants must attend all visits, receive study treatment, have blood drawn, complete questionnaires, have imaging scans done (ECG, ECHO or MUGA, CT, mammogram or breast MRI), keep a diary, have an eye exam, and provide a tumor sample.

Yes
 

Monali Vasekar
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05629585
SITE00001344
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Participant must be ≥ 18 years at the time of screening.
Histologically confirmed invasive TNBC.
Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab.14
No evidence of locoregional or distant relapse. Radiological scans before treatment are not required and should be obtained as per local institutional practice.

Exclusion Criteria:
Stage IV (metastatic) TNBC.
History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection,
History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease that has undergone potentially curative therapy
Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
Cancer
Experimental drug compared to an approved drug
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

Yes
 

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04266249
SITE00000861
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Histologically confirmed HER2-positive primary invasive breast carcinoma
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).

Exclusion Criteria:
Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer.
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)

This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.

The study is conducted in 2 parts. Part 1 consists of a screening period, treatment period and a completion period including a period of long term follow up. During part 1, you will be asked to answer questions about your health, participate in a physical examination that includes vital signs,height and weight, have testing done including an electrocardiogram, blood draws, urine sampling, pregnancy test, biopsy, and medical imaging. Part 2 consists of an additional screening period, treatment period and an end of treatment period.

70.00 per visit

Yes
 

Joseph Drabick
Irina Geier - at igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03969004
STUDY00013965
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
High risk cutaneous squamous cell carcinoma
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol

Exclusion Criteria:
Patients with blood cancer (hematologic malignancies) or other malignancies
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

Angelica Herbal Supplement AGN-Cognl.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)

The primary objective is to estimate the maximum tolerated dose of AGN-Cognl.Q. Subjects (total sample size n = 12 evaluable subjects), each for 4 ascending AGN-Cognl.Q dose levels in the form of AGN-Cognl.Q capsules (up to 10 capsules per dose), for single-dose safety metrics with a 1-week washout between doses.

Consented patients will be screened for physical exam and lab tests, and vital signs to establish eligibility (Visit 1, screening visit). The subjects will need to come into the research clinic in Hershey Medical Center on a weekly basis to take a single dose of AGN-CognI.Q by mouth in the morning for a series of blood draw over the span of the next 24 h to measure the amount of AGN Cognl.Q in their body. The total number of times the subjects will visit the clinic is 8 including a Screening visit (Visit 1) and an End of Treatment visit (Visit 8).

Yes
 

Monika Joshi
Kathleen Rizzo - at krizzo@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05375539
STUDY00020512
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Willingness and ability to given informed consent
agree to comply with all study procedures and attend all study visits to the best of their ability
male with age >= 40 years
Histologically confirmed prostate cancer diagnosis in the past
Not on concurrent androgen deprivation therapy

Exclusion Criteria:
Subjects with metastatic cancer as determined by chest and abdominal CT scan, PET/CT, MRI, bone scan within the past 12 months
Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy
Subjects who are receiving any other investigational agents
Uncontrolled intercurrent illness that would limit compliance with study requirements
Subjects currently taking herbal supplements containing AGN extract, including Cognl.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin
Cancer
Approved drug(s)
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,

A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)(M19-063)

This study is to determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in Acute Myeloid Leukemia patients when given as maintenance therapy following allogeneic stem cell transplantation. It also is to determine if venetoclax can be effective in combination with azacitidine to improve Relapse Free Survival in Acute Myeloid Leukemia patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation.

There are different phases of this study. The first phase is Screening, then there is the Treatment phase as well as a Follow up phase. Each phase will have testing and procedures that will require you to come to the study center.

50.00 Travel expenses

Yes
 

Shin Mineishi
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04161885
STUDY00015638
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Adult male or female ≥ 18 years old; and, for Part 2 only, male or female at least 12 years old.
Subject must be diagnosed with Acute Myeloid Leukemia by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic transplantation within the past 14 days.
Subjects that have previously been treated with venetoclax, can only be included if there was no history of disease progression during venetoclax treatment.
Grafts must be from one of the following sources: Bone marrow or peripheral blood stem cells or cord blood cells irrespective of degree of matching.
Subjects and/or their legally authorized representative (where permitted per local regulations) must voluntarily sign and date an informed consent form (and assent form for minors if required by applicable regulations)

Exclusion Criteria:
No malabsorption syndrome or other condition that precludes oral route of administration.
No history of any other malignancy within 2 years prior to study entry
Subject has no known evidence indicating leukemia relapse, which may include immunophenotype, cytogenetic or molecular methods.
No psychiatric illness/social situation that would limit compliance with the study.
No evidence of other clinically significant uncontrolled systemic infection.
Cancer
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,