Search Results Within Category "Cancer"
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.
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
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.
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.
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
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
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
Female
Breast Cancer Survivor
Preparing to Start AI medication
ER+ diagnosis
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
PSCI 23-121 Phase III Randomized Trial of Stereotactic ablativeradiotherapy (SAbR) for Oligometastatic Advanced RenalCarcinoma (SOAR)
This study is looking at patients with oligometastasis comparing chemotherapy and SABR with chemotherapy alone
•Blood counts and blood chemistry done at initiation and every three months to make sure you are not having any side effects from the study affecting your blood counts.•CT or MRI scans done at initiation and every three months to monitor the response of the treatment to your cancer•Physical exams done every three months to confirm your general well-being and to detect side effects from the study.Compete physical and well being form as set below:•Baseline•3 months from start of treatment•6 months from start of treatment•9 months from start of treatment•12 months from start of treatment•18 months from start of treatment•24 months from start of treatment
patient may not have brain metastases
Patient may have any RCC histology except a histology that has a sarcomatoid component.
Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization.
Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization.
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
Patients must not expect to conceive until after 6 months after the last dose of protocol medication
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
In order to participate in the QOL portion of the protocol, the patient must speak English or Spanish.
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.
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.
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).
A Phase II/III Study of Maintenance Nivolumab versus Observation in HPV Positive OPCA (PSCI# 20-016) (EA3161)
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it 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 be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years.This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment.
ECOG performance status of 0 or 1.
Patients must have oropharynx cancer that is p16-positive by immunohistochemistry
Adequate baseline organ and marrow function
Adequate baseline liver functionality
Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC
Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors
Patients must not have known hypersensitivity to nivolumab
Patients with evidence of distant metastases or leptomeningeal disease are excluded
PSCI 21-160: A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination with Venetoclax in Adult Patients with Acute Myeloid Leukemia
The purpose of the study is to evaluate the potential interaction between ASTX727 and venetoclax, the study drugs, evaluate the safety when the study drugs are taken together, and any potential benefits of taking the study drugs together.
The study is expected to last about 20 months. The amount of time you will be on study treatment or be followed up for health information as part of the study depends on how you respond to and tolerate the study treatment.Study assessments/procedures will occur during screening, a period in which your eligibility to enter the study is determined, while on treatment, at treatment discontinuation, when you decide to or are taken off the study treatment, and during the safety follow-up period. While in the study you must follow the directions given to you by the study staff. If you do not follow the directions given to you, you may not be able to continue taking part in the study. You must come to the study center for all visits, including the follow-up visit after your last dose of study treatment, unless you are told a telephone call is an acceptable option.
Newly diagnosed AML by World Health Organization (WHO) 2016 criteria
For Phase 1, ECOG 0-2. For Phase 2, ECOG 0-3.
Projected life expectancy of at least 3 months.
Known active hepatitis B or C infection
Known human immunodeficiency virus (HIV) infection
Severe renal impairment
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
College student attending 4 year university
English as primary language
Not attending a 4 year university
Does not have English as primary language
PSCI 23-144 NRG-LU008: PHASE III PROSPECTIVE RANDOMIZED TRIAL OF PRIMARY LUNG TUMOR STEREOTACTIC BODY RADIATION THERAPYFOLLOWED BY CONCURRENT MEDIASTINAL CHEMORADIATION FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER
Patients diagnosed withy inoperable node positive non small cell lung cancer will be randomized to with radiation therapy to all know sites of disease in the lung, followed by immunotherapy or radiation to the primary lung tumor, followed by radiation to the lymph nodes followed by immunotherapy
Participants will be required to come to all study visits, report to the study doctor any new medications, prescription or over the counter that they may be taking,
The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:
No evidence of distant metastases based on FDG PET/CT scan obtainedwithin 60 days of registration.
Primary tumor ≤ 7 cm;
Age ≥ 18;
Patients without identifiable primary tumor
Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of the primary SBRT and nodal radiation fields
Participants who are pregnant or unwilling to discontinue nursing.
Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy
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.
No evidence of metastasis
1 - 3 positive lymph nodes
May have had breast conserving surgery or mastectomy
35 years of age or older
History of ipsilateral breast cancer or DCIS
Synchronous or contralateral breast cancer
pT4 disease
Neoadjuvant Chemotherapy for breast cancer
EA8183 A Phase III Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE) (PSCI# 21-122)
This study is being done to answer the following question:Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
This study is being done to answer the following question:Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone?We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
Patient must have undergone a radical prostatectomy (RP) and must be preregistered to Step 0 of this study at least 6 weeks after but not more than 12 weeks after their radical prostatectomy.
Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer.
Patient must have an ECOG performance status of 0-2.
Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure).
Genomic Profiling of Urothelial Cancers Study
The objective of this protocol is to study urothelial cancer with detailed health history, tumor and/or normal tissues available for genomic sequencing to study cancers in the bladder, upper urinary tract, and urethra. There will be 3 groups of subjects in this study:1)Urothelial cancer patients receiving care at Penn State Health2)Relatives of patients with urothelial cancer3)High risk-cohort of individuals with family history of urothelial cancers or inherited cancer syndromes (such as Lynch syndrome) candidates for urothelial cancer screening evaluation
All subjects will be asked to fill out questionnaires to assess risk factors for urinary cancer and document family history of cancer. You will be asked to provide a blood sample and urine sample for genetic testing. Patients with urothelial cancer will be asked to allow us to test leftover tissue from a past or future biopsy to test cancer and/or normal cells for certain mutations. We may also ask you for a saliva sample, cheek swab, skin biopsy, or nail clippings for comparison.
personal or family history of bladder cancer
Patient and Provider Preferences for Breast Cancer Treatment Side Effect Prediction
This one-time survey seeks to understand both patient and provider perspectives of and preferences for a predictive test for side effects among breast cancer patients treated with an aromatase inhibitor (AI).
Complete a one-time electronic survey asking for opinions on a predictive test for side effects of aromatase inhibitor (AI) breast cancer treatments.
New diagnosis of non-metastatic breast cancer (stage 0-III) at Penn State Health within the last 5 years
Prescribed at least one AI as part of breast cancer treatment at least one year ago
Inability to provide consent in English or Spanish
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.
Diagnosis of High Risk B-ALL (Acute Lymphoblastic Leukemia) in CR1 (complete remission) after first-line treatment
Philadelphia chromosome positive (Ph+) ALL (Acute Lymphoblastic Leukemia)
Prior tyrosine kinase inhibitor therapy
PSCI 22-120 A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia
This trial will be comparing two doses of AAV2-hAQP1 against a placebo for patients with head and neck cancer who have severe dry mouth from receiving radiation.
Patient's will be required to come to all study visits, reports any signs and symptoms they are having and all medications they are taking. You will be required to come in for 2 pre screening visits that will include signing the consent, collecting of saliva, completing questionnaires, seeing the study doctor, having blood drawn, providing a urine specimen to see if you qualify to participate. If you meet the qualifications to participate you will have one visit in which you will receive medication to dry your mouth, than the study doctor will place the medication into the glands in your mouth that produce saliva. You will then be requires to come in the next week for additional saliva collection and to see the study doctor. After that you will come in monthly to see the study doctor too see how you are feeling,complete questionnaires and provide a urine specimen.
dependent upon miles traveled
Age ≥18 years
Able to understand the investigational nature, potential risks, and benefits of the study, and to provide valid informed consent to enroll in this study and in the long-term follow-up study
Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
No history of recurrent cancer or a second primary cancer
Any experimental therapy within 3 months prior to the first screening visit
Previous treatment with a gene or cell therapy
History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren’s disease)
Currently using systemic immunosuppressive medication(s)
STEEL: A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences.
Radiation treatment and hormonal therapy vs. Radiation treatment, hormonal therapy plus Enzalutamide in post-prostatectomy cancer recurrences
PSA level (≥0.2 ng/mL) within 90 days prior to registration.
Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
At least 1 of the following features: • Gleason score of 8-10 • Seminal vesicle invasion • Locoregional node involvement at radical prostatectomy • Persistently elevated PSA post-RP nadir
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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 <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.
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
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
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.
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
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
BCC018: A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma
This study is being done to learn if it is safe to add naxitamab to standard therapy during the Induction phase of care for patients with newly diagnosed high-risk neuroblastoma. Naxitmab is an immunotherapy agent which trains your immune system to target your tumor in a more specific way than chemotherapy does.
This study has 3 phases- screening, treatment, and follow up. If you join the study, during screening we will test a sample of your tumor along with your blood. The tumor sample will be obtained at the same time as you are having surgery or a biopsy. Other testing will be done to make sure you are eligible to receive treatment. If you are eligible for treatment, you will receive five 21 day cycles of anti-cancer medication (induction chemotherapy) along with naxitamab. You will have to stay in the hospital to receive this treatment for at least 6 days of each 21 day cycle. If your screening testing also shows a certain genetic change in your tumor, we may also add a medication that is targeted at that change. If your tumor does not respond adequately to the initial cycles, we may give up to three additional 21 day cycles of chemotherapy with naxitamab. You will also have procedures at certain timepoints during induction that are standard of care for your tumor. These include collecting stem cells for use later in your therapy after Cycle 2. After Cycle 4, you will have surgery to remove as much of the tumor as possible. The treatment phase will last about 8 months, after which you will be in follow up. During your time on the study, we will ask to collect research samples of blood, bone marrow, and tumor. We will be monitoring your progress and health throughout your time on treatment and in follow up.
≤ 21 years of age at initial diagnosis and > 12 months of age at time of enrollment
Receiving any investigational drug
BCC017: Precision mEdicine and Adoptive Cellular tHerapy for the treatment of recurrent neuroblastoma and newly diagnosed diffuse intrinsic pontine glioma (DIPG)
This study is being done to learn if a vaccine made in the laboratory from your tumor and your immune cells is safe to give to you to treat your tumor. It is believed that the body’s immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use your tumor and immune cells from your blood to make a vaccine that we hope will stimulate your T-cells to kill tumor cells and leave your normal cells alone.
You will need routine (standard of care) testing for your tumor, as well as research tests and procedures including further analysis of your tumor sample, generation and review of a personalized genetic report, and procedures to collect certain cells for different infusions and creation of specialized cellular vaccines. You will then be offered and placed on a treatment plan. As a subject in this study you will remain in this study until you complete vaccine therapy as long as you have no disease progression or unless you need to come off study for another reason.
For Neuroblastoma must be >12 months and ≤ 30 years of age
For DIPG must be ≥ 3 years and ≤ 30 years of age
Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection
20-081, Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combo with Axitinib in Advanced RCC
Determine the maximum tolerated dose or maximum administered dose of MEDI5752 combined with axitinibAssess the safety and tolerability of MEDI5752 combined with axitinibAssess the antitumor activity of MEDI5752 combined with axitinib
The study will consist of 3 periods: screening, study treatment, and follow-up. You are expected to keep all of your study appointments and complete all study procedures.
$75 Per visit
Histologically or cytologically proven advanced RCC
Advanced RCC not previously treated in that setting
Must have at least 1 measurable lesion according to RECIST v1.1
Life expectancy ≥ 12 weeks
Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC
History of active primary immunodeficiency
History of organ transplant
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.
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
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)
Carvedilol in Metastatic HER-2+ Breast Cancer for Prevention of Cardiac Toxicity (PSCI# 20-135) (S1501)
The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.
The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.
Patients must be ≥ 18 years of age.
Patients must have a complete physical examination and medical history within 28 days prior to registration.
Patients must not be dialysis dependent
Patients must be able to swallow tablets.
Patients have uncontrolled asthma.
Patients who are pregnant or nursing
Patients who are unable to swallow tablets.
Patients who do not have adequate hepatic function
Protocol NRG-LU007: RAndomized Phase II/III Trial Of Consolidation Radiation + Immuno-therapy for ES-SCLC: RAPTOR trial (NCT # NCT04402788) (PSCI# 20-118)
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment. The addition of radiation to the usual treatment could shrink your cancer or prevent it from returning. 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 study approach increases the life of patients or extends your time without disease compared to the usual approach.
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment.
measurable disease (per RECIST) and 3 or fewer observable liver metastases and no evidence of progressive disease at enrollment
Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody
ECOG Performance Status of 0-2 at the time of registration
Age ≥ 18
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 5 years prior to randomization
Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration
Patients who have had immunotherapy-induced pneumonitis
History of recent myocardial infarction within 6 months prior to registration
Phase III IGRT and SBRT VS IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer (NRG-GU005) (PSCI# 19-073)
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
The purpose of this study is to compare any good and bad effects of using stereotactic body radiation therapy (SBRT), a technique that gives treatment in a shorter amount of time compared to the usual radiation therapy. SBRT is experimental for treating this type of cancer. SBRT uses special equipment to position a participant and precisely deliver radiation to tumors in the body. Both the study and the usual radiation treatments use daily images to guide the radiation treatment to protect normal tissue. The study treatment, treatment over a shorter amount of time, may prevent the tumor from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach using SBRT is better, the same, or worse than the usual approach. To be better, the study treatment should increase the time without the cancer coming back by six months or more compared to the usual approach, and show improvements in side effects to the bladder or rectum.
Previously untreated localized adenocarcinoma of the prostate
Clinical stage by digital rectal exam of either T1c or T2a/b
The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imagining modalities including MRI or CT scan
Age is 18 years or older
Definitive T3 disease on MRI
Prior or current invasive malignancy with current evidence of active disease within the past 3 years
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
(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.
Age ≥ 18 years
Karnofsky performance status greater than or equal to 70%
Hemoglobin ≥8 g/dL
Platelet Count ≥ 100,000/mm3
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
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
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
Must not currently have significant cardiovascular or respiratory disease
Must not be claustrophobic
22-061 Relugolix Versus Leuprolide in Patients with Prostate Cancer: A Randomized, Open-Label Study to Assess Major AdverseCardiovascular Events (REPLACE-CV)
The purpose of this research study is to compare and see if medications used in ADT treatment, either relugolix or leuprolide acetate, lower the risk of cardiovascular events in patients with prostate cancer. You (or your caregiver) will be asked to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)
Participants will be required to complete questionnaires electronically (such as computer, tablet, or smartphone) and/or share information via phone calls every three months until the end of your participation in the study. You will receive the study medications for treatment (either relugolix or leuprolide acetate)
$150 per year
Is a male and 18 years of age or older on the day of signing and dating the informed consent form;
Patient has sufficient cognitive function in the investigator’s opinion to complete the questionnaires and other activities related to the study
Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
Is, in the opinion of the investigator, a candidate for at least 1 year of continuous ADT for the management of prostate cancer with one of the following clinical disease state presentations:Evidence of biochemical (prostate-specific antigen
Any major cardiovascular or cerebrovascular procedures planned within 1 month after enrollment;
Patients with QT interval corrected for heart rate (QTc) determined using Fridericia’s formula (QTcF; QTcF = QT/[R-R interval {RR}^0.33]) > 470 msec within 6 months of screening
Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) at the time of screening
Previously received GnRH receptor agonist
NMTRC014: NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)
A study of DFMO for patients with neuroblastoma in remission.
Participating in this study requires that you visit the Penn State health Medical Center multiple times over the course of the full study for evaluations (physical exam, blood draw, urine analysis, etc.) and scans (MRI/CT, MIBG).If you agree to take part, you will receive treatment on this study for about 2 years and will be followed for survival for 5 years after the last dose of study drug. You will be asked to return to the research site approximately 15 times.
Must be in complete remission (CR).
Tests and scans will be required to confirm remission.
Patients who are currently receiving another study drug may not participate.
Patients who are currently receiving other anticancer agents may not participate.
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)
This study is a phase 3 study that will be comparing recurrence-free survival (RFS) between patients withlocally advanced renal cell carcinoma randomly assigned toperioperative nivolumab in conjunction with radical or partialnephrectomy with patients randomized to surgery alone.
You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possiblesigns of recurrence (close observation)
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency