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125 Study Matches

PSCI 21-191: CG-745-2-08

The purpose of this voluntary research study is to learn more about an investigational drug (also known as the “study drug”) called ivaltinostat as a possible treatment for metastatic pancreatic adenocarcinoma.

Participants will be required to attend all study visits, receive drug treatment, have blood drawn, imaging assessments and tumor biopsy if needed

Yes
 

Nelson Yee
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
NCT05249101
SITE00001325
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Inclusion Criteria:
Provision of informed consent prior to any study specific procedures.
Age: ≥18 years
Histologically or cytologically confirmed pancreatic adenocarcinoma
Patients with or without radiographically measurable disease per RECIST v1.1 are eligible to participate.
Patients with metastatic disease are eligible.

Exclusion Criteria:
For Phase 2, radiographic progression of tumor per RECIST 1.1 between start of first line FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma and randomization.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Any previous treatment with a histone deacetylase (HDAC) inhibitor, including ivaltinostat.
Other primary cancers.
Cancer
Experimental drug compared to an approved drug
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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
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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
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Hershey, PA ,

EA9161: A Randomized Phase III Study of the addition ofVenetoclax to Ibrutinib and Obinutuzumab versus Ibrutiniband Obinutuzumab in Untreated Younger Patients withChronic Lymphocytic Leukemia (CLL)

The is a drug study to compare the progression freesurvival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.

pt will either get ibrutinib and obinutuzumab, plus venetoclax for up to 19 months or will get ibrutinib and obinutuzumab until doctor decides disease is getting worse or the side effects become too severe. After 19 cycles completed, doctor will follow condition every 90 days until progression and watch for side effects. They will check pt every 3 months for 2 years. After that, they will check pt every 6 months for 3 years. After that, they will check pt every 12 months for 5 years

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
NCT03701282
SITE00000485
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Inclusion Criteria:
Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.

Exclusion Criteria:
No deletion of 17p13 on cytogenetic analysis by FISH
No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
Cancer
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Hershey, PA ,

PSCI 24-015 S2212 SHORTER ANTHRACYCLINE-FREE CHEMO IMMUNOTHERAPY ADAPTED TO PATHOLOGICAL RESPONSE IN EARLY TRIPLE NEGATIVE BREAST CANCER (SCARLET), ARANDOMIZED PHASE III STUDY

To see if participants with early stage triple negative breast cancer randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have a better breast cancer event-free survival (BC-EFS)compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab.

keep all study appointmentsreport to your study team any side effects or any changes in medication

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05929768
STUDY00024644
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Inclusion Criteria:
Participants must have histologically confirmed ER-negative, PR-negative, and HER2-negative breast cancer
Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or MRI within 49 days prior to randomization.
Participants must not have metastatic disease
Participants must not have received prior systemic therapy or radiation therapy
Participants must be ≥ 18 years old.

Exclusion Criteria:
Participants must not be pregnant or nursing.
Participants must not have a prior or concurrent malignancy
Participants must not have received a live vaccine within 30 days prior to randomization.
Participants must not have active autoimmune disease
Participants must not have severe or active infections
Cancer
Approved drug(s)
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Hershey, PA ,
Reading, PA ,

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.

Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps

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
NCT05467891
STUDY00022070
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Inclusion Criteria:
Written informed consent and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures.
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.

Exclusion Criteria:
Patient with a known hypersensitivity to any of the excipients of ribociclib.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety
Cancer
Experimental drug compared to an approved drug
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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
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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
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Hershey, PA ,

PSCI-22-042: M23-362 Epcoritamab monotherapy R/R DLBCL or Classic FL (Previously Grade 1-3a) outpatient

The purpose of this voluntary research study is to optimize the approach to safely administer a study drug called epcoritamab in the outpatient/non-hospital setting.

Complete interview, questionnaires, and subject diaryECGClinical laboratory testsBiopsy sample, archival or freshCT/PET-CT/MRITreatment of epcoritamab

Yes
 

Seema Naik
Laurie ONeal - at loneal1@pennstatehealth.psu.edu or 717-531-0003, ext=343429
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05451810
SITE00001234
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Inclusion Criteria:
Subjects must voluntarily sign and date an informed consent,
Adult male or female, at least 18 years old
Diagnosis of R/R DLBCL or R/R FL grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to WHO classification 2016 or WHO classification 2008 based on representative pathology report
Subject must have 1 or more measurable disease sites:  Fluorodeoxyglucose (FDG)-avid lymphomas:
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2

Exclusion Criteria:
Central nervous system (CNS) involvement
inadequate organ functions
central nervous system involvement
history of primary mediastinal lymphoma.
history of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy.
Cancer
Not applicable
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Hershey, PA ,

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C mutation (MRT849-001)

This study is to determine the maximum tolerated dose (MTD) of MRTX849 using one or more dosing regimens. The regimens includ using MRTX849 or in combination with Afatinib, Cetuximab, or Pembrolizumab. The study will also look at how it can be tolerated MRTX849 when its taken with food.

If you take part in this research, your major responsibilities will include: •Keep your study appointments and complete all study assessments. If you cannot keep anappointment, please contact study personnel (your study doctor or study staff) as soon aspossible to schedule a new appointment.•Inform your study personnel about any symptoms, changes in medications, doctor's or nurse'sappointments, or hospital admissions that you may have had.•Agree to not participate in any other clinical research study•Inform study personnel if you believe you or your partner might be pregnant•Inform study personnel if you change your mind about participating in the study.•Inform your other doctors that you are taking part in this study.•Avoid grapefruit and grapefruit juice.•Avoid herbal medications and preparations including but not limited to St. John’s wort, Kava,turmeric/curcumin, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA),yohimbe (yohimbine), saw palmetto, and ginseng.•Avoid medications that are processed by liver enzymes, your doctor will counsel you on these.•Avoid medications known to have risk of changing the electrical activity in the heart, your doctorwill council you on these.•For your safety, you must tell the study doctor or nurse about all the prescription drugs, herbalproducts, over-the-counter drugs (OTC), vitamins and other supplements you are taking.Check with the study doctor before starting any new medicines (including prescription, OTCdrugs, vitamins and herbal supplements) or changing doses of medications that you arealready taking.

Yes
 

Patrick Ma
Irina Geier - at igeier@pennstatehealth.psu.edu or 717-531-8678
Molecular and Precision Medicine (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03785249
STUDY00014803
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Inclusion Criteria:
Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation.
Unresectable or metastatic disease.
Presence of tumor lesions to be evaluated per RECIST 1.1:
Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1.

Exclusion Criteria:
Active brain metastases.
Patients with carcinomatous meningitis
History of significant hemoptysis or hemorrhage within 4 weeks of the first dose date
Undergone major surgery within 4 weeks of first dose date
History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications
Cancer
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Hershey, PA ,

Dysgeusia and Anosmia in Head and Neck Cancer Patients: Long Term Outcomes

The primary aim of this study is to understand taste changes after head and neck cancer treatment, especially long term taste disturbance, using various methods including online surveys, Teams interviews, at home taste and smell tests, and MRIs.

The purpose of this voluntary research study is to identify taste changes in patients treated for head and neck cancer. We are recruiting healthy participants over the age of 40 as well as head and neck cancer survivors who were treated 3 or more years ago. The overall study consists of multiple parts, which are explained along the way. You can choose to participate in this portion, which is an online survey, and nothing else, or all of the invited components. •The survey will take approximately 10 minutes of your time. •Completion of this survey is voluntary and you are not required to complete it if you do not wish to do so.•At the end of the survey you will be asked about your willingness to participate in other portions of this study. These include at-home taste and smell tests over Teams and a Teams interview about your taste and smell function. Participating in these tasks is optional and not required. If you complete the smell and taste tests at home you may be invited to have an MRI scan.

Max of $75: No compensation for the survey, $15 giftcard for 1-hour interview (optional), $15 giftcard for at-home taste/smell tests (optional), $50 giftcard for MRI at Hershey Med Center (optional).

No
 

Neerav Goyal
Hanel Eberly - at HNCtaste@pennstatehealth.psu.edu
Otolaryngology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019457
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Inclusion Criteria:
Able to give consent
Over the age of 40
English Speaking

Exclusion Criteria:
Under 40 years of age
have undergone a total glossectomy
currently have an upper respiratory infection, sinus infection, or ear infection
Cancer
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PSCI-22-063: NRG-GU011 NRG Promethean

This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.

Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.

Yes
 

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

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05053152
SITE00001224
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.

Exclusion Criteria:
Evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

AYA-CONNECT: A qualitative study to inform creation of a social network-based peer intervention for adolescent/young adult cancer survivors

In this study, in Aim 1 we will conduct focus groups of adolescent/young adult cancer survivors (AYACS) (at least 15 total AYACS) 15-25 years old to understand their perspectives on the importance of peer connection and social connectedness during and after cancer treatment, the role of an intervention to foster peer connections, and suggestions/feedback on designing AYA-CONNECT (an AYACS-peer network intervention) including delivery format, structure, and content to promote life goals and health-related behaviors. In Aim 2 we will further explore ways to design AYA-CONNECT through interviews of pairs of AYACS and a nominated peer.

You will participate in one focus group and/or interview that will last about 1 hour.

$40

No
 

Pooja Rao
Pooja Rao - at prao2@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
STUDY00024174
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Inclusion Criteria:
Participant age 15-25 years old at time of cancer diagnosis and within 5 years of initial cancer diagnosis
Participant is receiving or has received any oncologic care at Penn State Health Children’s Hospital or Penn State Cancer Institute
Participant fluency in written and spoken English for participants > 18 years old

Parent and participant fluency in written and spoken English for participants < 18 years old
Access to computer or smartphone

Exclusion Criteria:
Non-English speaking
Participants with cognitive or physical inability to participate in study
Cancer
Not applicable
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BCC020: A Dose Escalation Study Using Difluoromethylornithine(DFMO) and AMXT-1501 followed by a Randomized Controlled Trial of DFMO with or without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas

The purpose of this study is to evaluate the investigational drug AMXT-1501 (a pill taken by mouth) in combination with the study drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food &amp; Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.

You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06465199
STUDY00025296
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Inclusion Criteria:
0-21 years of age at diagnosis

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
Prefer not to display
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Hershey, PA ,

PSCI 24-040 A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]

This protocol is comparing two types of surgery, one with the removal of the ovaries, fallopian tubes and uterus against removal of the fallopian tubes and uterus in subjects how are between 35 and 50 with the BRCA1 mutation..

Participants must be carriers of the BRCA1 gene mutation. This trial involves going to the operating room to have either their fallopian tubes removed or their ovaries and fallopian tubes removed. A vaginal ultrasound will be done. you will have blood drawn and a pregnancy test done. This will happen before surgery.

Yes
 

Shaina Bruce
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04251052
STUDY00025098
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Inclusion Criteria:
Individuals 35-50 years of age, inclusive.
At least one intact ovary and fallopian tube
Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient.
Patients may be premenopausal or menopausal.
Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.

Exclusion Criteria:
Individuals with a history of any prior cancer
Prior history of ovarian cancer,
Patients medically unfit for the planned surgical procedure.
Patients with abnormal screening tests
Cancer
Not applicable
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Hershey, PA ,

PSCI-23-089: CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II study

Researchers in this trial will be using a combination of two drugs to determine if the combination will help in treating cancer by shrinking tumors and controlling cancer growth.

You will need to come to the clinic for at least six visits while you are taking the study medication. Those visits will include see the study doctor, having blood drawn, and giving you the study drug. When you are no longer taking the study drug you will be seen about 2 months after that followed by phone follow ups between 6 and 8 months after stopping the study drug and then every year for 2 years. Those yearly visits can also be done by looking at you medical record.

Yes
 

Takefumi Komiya
CI CTO at PSCI-CTOPennstatehealth.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
NCT04467723
STUDY00024667
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Inclusion Criteria:
Participant or legal representative is able to provide written informed consent prior to performing any protocol-related procedures.
Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer.
Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
Life expectancy of at least 6 months
Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease.

Exclusion Criteria:
Has a known hypersensitivity to atezolizumab or pirfenidone.
Has uncontrolled diabetes.
Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment.
Is pregnant or breast feeding.
Has drug-induced pneumonitis ( e.g. from amiodarone, methotrexate or nitrofurantoin)
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)

Participants in the PIVOT-006 study will either receive surgical treatment plus cretostimogene or surgical treatment alone.This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by CG0070 vs TURBT for the treatment of patients with IR-NMIBC.The purpose of this study is to see if cretostimogene can reduce the risk of your bladder cancer returning, or coming back as quickly as if you did not receive cretostimogene. People in the study will continue to be monitored by cystoscopy and pathology to see how long it takes for thecancer to return.Who May Be Eligible to Take Part In This Study:People with:• Bladder Cancer that has not invaded the muscle (Non-Muscle Invasive Bladder Cancer) • Intermediate-Risk Disease • Over 18AllTreatment:18All patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period.Main Meausure:Patients who have recurrence of bladder cancer after receiving surgery plus cretostimogene compared to patients who receive surgery alone.

if you decide to take part in this study and meet all of the requirements, all patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. You will receive 6 treatments, once per week for 6 weeks in a row. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period. There will be up to 16 visits with blood draw and/or urine colelction. As a part of screening, efficacy and follow up for this study, you might have to have cystoscopy ( up to 6), urine cytology (up to 6), TUBRT or vladder mapping or CT urogram over a 3 year month period.

Yes
 

Hong Truong
Seyma Demirsoy - at sdemirsoy@pennstatehealth.psu.edu or 717-531-0003, ext=282616
Urology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06111235
STUDY00024123
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Inclusion Criteria:
Bladder Cancer that has not invaded the muscle (Non-Muscle Invasive Bladder Cancer)
Intermediate-Risk Disease
Is ≥18 years of age on day of signing informed consent.
Demonstrates adequate organ function
Is willing to comply with study mandated cystoscopies, urine cytology, CT urograms, TURBTs/biopsies, and other procedures

Exclusion Criteria:
Has current or prior evidence of high-risk Non-Muscle Invasive Bladder Cancer (NMBIC)
Has disease that cannot be completely resected.
Has current or history of muscle-invasive cancer or locally advanced or metastatic bladder cancer
Has a history of High-grade or Low-Grade urothelial cancer
Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of randomization.
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

We are asking you to take part in this voluntary research study because you have a brain tumor (glioblastoma) that has gotten worse despite first treatment.The purpose of this voluntary research study is to is to learn if the SonoCloud-9 (SC9) implantable device can be used in combination with Carboplatin chemotherapy to help control glioblastoma at recurrence. Neither Sonocloud-9 (SC9) in combination with Carboplatin chemotherapy is not FDA approved.

As part of your routine care, you will be asked to undergo surgery to remove the tumor that has come back. You will be randomized into one of the treatment groups. If you are in the study drug group the surgeon will insert the SonoCloud-9 device (SC9) implant into the skull bone at the end of the tumor resection surgery. If you are in the routine treatment group, the surgeon will close the wound without implanting the SC9 device.The treatment itself will start within 12 to 21 days after the randomization.-If you are in the study drug group you will receive up to 7 doses (every 3 weeks) of Carboplatin at the same time the SonoCloud-9 device is being activated. Further details on the procedures are described below. A brain MRI (Magnetic Resonance Imaging) scan will be performed after the first cycle as part of the research to evaluate opening of the BBB (blood-brain barrier). -If you are in the routine treatment group, you will receive up to 4 doses of Lomustine (every 6 weeks), or, if considered as best appropriate, up to 6 doses of Temozolomide (every 4 weeks). Additional in-person hospital visits or telehealth consultations by video or phone will be performed at regular intervals.

$350.00

Yes
 

Brad Zacharia
Micaiah Grien - at mgrien@pennstatehealth.psu.edu or 717-531-0003, ext=283063
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05902169
STUDY00023862
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Inclusion Criteria:
Candidate for surgical resection (craniotomy)
Received prior first line therapy
First disease progression
Proven glioblastoma
At least 18 years old

Exclusion Criteria:
Contra-indication to Carboplatin, lomustine or temozolomide
Medical need to be on continued anti-platelet aggregation therapy or coagulation
Peripheral neuropathy
Uncontrolled epilepsy
Known sensitivity/allergy to gadolinium
Cancer
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Hershey, PA ,

PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTIONRADIATION FOR HIGH-RISK PROSTATE CANCER

This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.

Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.

Yes
 

Zain Siddiqui
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05946213
STUDY00025462
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18

Exclusion Criteria:
No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
Cancer
Not applicable
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Hershey, PA ,

BCC021: Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors

The purpose of this study is to evaluate the investigational drug Silmitasertib (CX-4945) (a pill taken by mouth) in combination with chemotherapy drugs standardly used for your tumor type. An investigational drug is one that has not been approved by the U.S. Food &amp; Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.

You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06541262
STUDY00025626
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Inclusion Criteria:
Less than 30 years old at initial diagnosis

Exclusion Criteria:
Currently receiving another investigational drug
Cancer
Prefer not to display
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Hershey, PA ,

PSCI 23-110 CA209-6K6 An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer

We are asking you to take part in this voluntary research study because you have lung cancer that will require surgery, chemotherapy, and possibly immunotherapy. The study involves chemotherapy and immunotherapy given during the 6 weeks prior to surgery.

In person visits for Screening, Treatment and Follow-up visits. Treatment is given monthly on day 1,22 &amp; 43. Special test will be conducted at these time periods such as Physical Exam, Blood Draws and CT/Pet scans.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05500092
STUDY00025056
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Inclusion Criteria:
Age > 18 years at time of study entry
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.
Hemoglobin ≥ 9.0 g/dL

Exclusion Criteria:
Participation in another clinical study with an investigational product during the last 3 weeks
Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab, with the exceptions of intranasal, inhaled, topical steroids
Patients with Grade ≥2 neuropathy
History of allogeneic organ transplant.
History of hypersensitivity to nivolumab or any excipient
Cancer
Approved drug(s)
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Hershey, PA ,

The Application of Mixed Methods and Social Network Analysis to Develop a Novel Measure of Social Connectedness for Adolescent/Young Adult Cancer Survivors (AYACS)

The purpose of this voluntary study is to evaluate adolescent and young adult cancer survivors’ (AYACS) social network changes over the first year after being diagnosed with cancer. This study is also exploring difference is AYACS’ social networks based on rurality. With this information, a better understanding on rural and non-rural AYACS’ social networks will be used to improve care and available resources.

As a study participant, you will complete two study visits—one after cancer diagnosis and the second one year after cancer diagnosis. Both visits should take up to about one hour and can be completed both in person and remotely. Each visit will entail the following activities: oA 30-minute interview over a secure video conference software (Microsoft Teams). The session will be audio and video recordedoSome of your contact and medical/demographic information will be collected via chart review and/or a survey. This includes but is not limited to phone number, email, race, gender, insurance, diagnosis, and other common demographic information.oNetwork Canvas social network analysis “interview” (the program’s term for a survey)oSurveys assessing social isolation and emotional support

$100.00

No
 

Pooja Rao
Pooja Rao - at prao2@pennstatehealth.psu.edu
Pediatrics: Hematology/Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT00000000
STUDY00025425
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Inclusion Criteria:
Participant age 15-29 years old at time of cancer diagnosis
Within 120 days of cancer diagnosis
Participant receiving cancer treatment at Penn State Health
United States resident and English speaking
Access to computer or smartphone

Exclusion Criteria:
Relapsed cancer
Cognitive inability to participant in study
Mental & Behavioral Health, Cancer
Not applicable
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PSCI 24-077 A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor

this trial is looking at introducing a medication to control blood sugars elevations caused by CDK inhibitors.

Participants must agree to come to all study visits, report any new medications to the study team, agree to having blood work done at least 8-12 hours after eating something, take study medication as directed.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05570253
STUDY00025502
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Inclusion Criteria:
Patient is an adult female ≥18 years old at the time of informed consent(s) and has signed informed consent(s) before any trial related activities and according to local guidelines.
Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
Patient has identified PI3K pathway
Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:
Patient has measurable disease

Exclusion Criteria:
Patient has inflammatory breast cancer at screening.
Patient has known primary brain malignancy,
Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib or capivasertib, or to any of their excipients.
Patient has had major surgery within 30 days
Patient has uncontrolled human immunodeficiency virus (HIV) infection.
Cancer
Experimental drug compared to an approved drug
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PSCI 24-013 A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA

This trial is looking at what happens to muscle invasive bladder cancer when adding cevumeran to Nivolumab

Participants will be required to keep all study appointments, tell the study doctor about all medications they are taking, report any side effects to the study doctor.

$202 for each visit completed

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
NCT06534983
STUDY00025674
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Inclusion Criteria:
muscle-invasive UC of the bladder identified based on computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest as cT3-T4 or N .
Surgical resection of muscle-invasive UC of the bladder or upper tract
Cisplatin ineligible
Absence of residual disease and absence of metastasis,
ECOG performance status of 0 or 1

Exclusion Criteria:
Pregnancy or breastfeeding,
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Any prior neoadjuvant immunotherapy
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Absence of spleen
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).

You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.

Yes
 

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

All
All
This study is NOT accepting healthy volunteers
NCT06540963
STUDY00025733
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Inclusion Criteria:
Age ≤ 21 years at initial diagnosis
Age >12 months of age at enrollment
Age 6 years or older for safety run in

Exclusion Criteria:
Age less than 1 year
Currently receiving another investigational drug
Cancer
Prefer not to display
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Hershey, PA ,

A Confirmatory Phase 3 Mutlicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).

The purpose of this trial is to evaluate the safety and efficacy of 18 weeks of HyBryte (topical gel) treatment in combination with visible light therapy in subjects with cutaneous T-cell lymphoma when compared to placebo (no active ingredient). Cutaneous T-cell lymphoma (CTCL), of which the most common early stages are also known as mycosis fungoides (MF), is the most common type of T cell lymphoma. Participants will be enrolled in this trial for 30 weeks and will follow up at the clinic site every 4 weeks following the last trial treatment for a total of 12 weeks.

Participants will attend in person visits over 30 weeks. At different timepoints throughout the study participants will have their skin evaluated and photographed, have blood drawn, have an ECG done, and apply the study medication as directed by the study team.

Yes
 

Christopher Bazewicz
Samantha Gettle - at dermatologyclinicaltrials@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06470451
STUDY00025614
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Inclusion Criteria:
Participants must have a clinical diagnosis of CTCL (MF)
Participants must have a minimum of 3 evaluable, discrete lesions
Participants must be willing to follow the clinical protocol and voluntarily give their written informed consent

Exclusion Criteria:
Certain medications are not allowed to be used during the study; study coordinator will discuss.
Participants with extensive skin disease may not be eligible to participate; investigator will discuss during skin evaluation
Certain medical conditions may not be eligible to participate; study coordinator will discuss further.
Skin Conditions, Cancer
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

PSCI 24-018 Phase 1, open label clinical trial to treat Stage IV cancer patients with multiple patient-specific mutated cell surface proteins with chimeric antibodies

This study will examine if giving patients their cells that have been modified in the lab will help control their cancer.

Subjects will be required to come to all visits. Each treatment will take 2-5 hours and there will be a total of 10 treatments over a 14 week period.

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
NCT06674538
STUDY00025562
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Inclusion Criteria:
Stage IV cancer of the following types: breast cancer, colon cancer, esophageal cancer, kidney cancer, lung cancer, lymphoma, melanoma, ovarian cancer, pancreatic cancer, bladder urothelial carcinoma, and stomach cancer.
Subjects who have refractory or progressive disease after at least 1 line of systemic treatment
Subjects must have measurable disease

Exclusion Criteria:
Insufficient tumor tissue for whole exome sequencing.
Known human immunodeficiency virus infection.
Subjects who have received any cytotoxic treatment within 3 weeks of antibody treatment.
Subjects who have received any radiotreatment to the primary sample site within the last 14 days
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Research on Survivorship Experiences: Disparities in cancer-related outcomes between rural and non-rural cancer survivors in the catchment areas of the Big 10 Cancer Research Consortium's Population Science Working Group

The objective of this cross sectional survey study is to describe the social and psychological outcomes of cancer survivors and characterize the disparities between rural and non-rural cancer survivors. We will collaborate will members of the Big 10 Cancer Research Consortium's Population Science Working Group to invite cancer survivors in rural and non-rural communities to complete one online survey, with each site targeting cancer survivors in their catchment areas. At Penn State, we will target recruitment to cancer survivors living in Pennsylvania. We plan to enroll 150 participants. It will take participants 30-40 minutes to complete the study and they will receive a $15 Amazon gift card for their time and effort.

If eligible, study participants will be asked to complete one online survey about their experience as a cancer survivor. Potential participants will first complete a REDCap screening form, if eligible, they will view the consent form. If they provide consent, they can complete the survey. A member of the Penn State study team will call the participant to confirm eligibility and once confirmed, will issue a $15 Amazon e-gift card. The entire study should take between 30-40 minutes to complete.

$15

No
 

Jennifer Moss
Leonard Kishel - at Casper@pennstatehealth.psu.edu or 717-531-0003, ext=321657
Family and Community Medicine (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00000000
STUDY00025475
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Inclusion Criteria:
diagnosis of primary pathologic breast, colorectal, lung, melanoma, prostate, uterine, endometrial, or blood cancers (leukemia, lymphomas)
non-metastatic cancer
1-5 years post completion of active treatment
no current evidence of cancer
living in certain counties in south central Pennsylvania

Exclusion Criteria:
no internet access
cannot speak or read English
unable to provide informed consent
less than 18 years old at time of cancer diagnosis
Cancer
Not applicable
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Maintenance Obinutuzumab for primary central nervous system lymphoma complete or partial responders

The study will compare participants with primary central nervous system lymphoma which responded to initial treatment and are thereafter treated with Obinutuzumab (the study drug), with participants with primary central nervous system lymphoma which responded to initial treatment and are not treated with the study drug.

In addition to your routine care, you will be “randomized” into one of the study groups described below. You will have a MRI of your brain approximately every three months (plus or minus two weeks) for two years. You will undergo a neurocognitive assessment and complete a quality-of-life questionnaire two years after study entry.Group A – Obinutuzumab ArmIf you are in the first group ("Group A") you will be given the study drug every two months for two years. Every two months you will have your vital signs taken, your blood drawn (one to two tablespoons), and you will be given the study drug through an IV infusion into your vein. Group B – No Obinutuzumab ArmIf you are in the second group ("Group B") every six months you will have your vital signs taken and your blood drawn (one tablespoon).

Yes
 

Dawit Aregawi
Micaiah at mgrien@pennstatehealth.psu.edu or 717-531-0003, ext=283063
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06175000
STUDY00024845
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Inclusion Criteria:
CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis
Must have undergone first-line treatment with high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy
Must be within 75 days of completion of first-line treatment regimen at the time of randomization
18 years or older

Exclusion Criteria:
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Clinical evidence of extra-CNS (systemic) non-Hodgkin lymphoma.
Known hypersensitivity to any of the study drugs.
History of other malignancy that could affect compliance with the protocol or interpretation of results
Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 24-139 NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED

This trial will examine if disease progression improves with Fractionated vs. Steriotactic Radiosurgery.

Participants must agree to the type of radiation they are randomized, keep all appoiintments and rpoert any side effects.

Yes
 

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

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06500455
STUDY00026009
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of one of the following solid tumor malignancies within 5 years prior to registration:
Patients must have at least 1 and up to 8 total intact brain metastases
All brain metastases must be located outside of the brainstem
No more than 2 lesions planned for resection
No known leptomeningeal disease

Exclusion Criteria:
Not Pregnant and Not Nursing
No prior radiotherapy to the brain
No active infection
No hepatic insufficiency
No chronic obstructive pulmonary disease exacerbation
Cancer
Not applicable
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Hershey, PA ,

PSCI 23-002 CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2-Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

We are asking you to take part in this voluntary research study because you have ER+/HER2- early breast cancer with no evidence of disease following surgery. The purpose of this voluntary research study is to better understand the studied disease and associated health problems.

Participants will be required to come to all study visits, take the medication an instructed, let the study team know what medications you are taking, especially over the counter ones and to report any changes in how you are feeling.

Yes
 

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

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05952557
STUDY00024347
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Inclusion Criteria:
Capable of giving signed informed consent
Patient must be ≥18 years
histologically confirmed ER+/HER2- early-stage resected invasive breast cancer

Exclusion Criteria:
inoperable locally advanced breast cancer
a history of previous breast cancer
Chronic gastrointestinal disease
Major surgical procedure or significant traumatic injury within 2 weeks of randomisation
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 24-041 Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)

This trial will compare the use of elacestrant versus standard endocrine therapy in those who are node positive, ER +, Her2 - with high risk of the cancer coming back

Participants will be expected to come to all visits, take all study medication as instructed by the study doctor, report any new medications, prescription or over the counter, report all side effects.

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
NCT06492616
STUDY00025850
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Inclusion Criteria:
Adult women or men aged ≥18 years old, or older if required by local regulations, at the time of informed consent signature.
Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and ISH-negative)]
Participants considered at high risk of recurrence
Participants who have received at least 24 months but not more than 60 months of endocrine therapy
Participants are to be between 2 to 6 years from the date of curative surgical resection

Exclusion Criteria:
Participants with inflammatory breast cancer.
Participants with stage IV metastatic breast cancer.
History of any prior (ipsilateral and/or contralateral) invasive breast cancer
Major surgery within 4 weeks of starting study therapy
Cancer
Experimental drug compared to an approved drug
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,