Search Results Within Category "Cancer"
Phase 2 Study of Bladder-SparIng ChemoradiatioN with Durvalumab (PSCI# 19-072) (EA8185)
The purpose of this study is to compare the usual treatment of chemotherapy and radiation to adding MEDI4736 (durvalumab) immunotherapy to the usual treatment. The addition of MEDI4736 (durvalumab) immunotherapy to the usual treatment may help shrink your cancer better than the current standard of care or usual approach for bladder cancer. But, it could also cause side effects, which are described in the risks section.This study will help determine 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 study approach increases the life of patients by 6 months or more compared to the usual approach.
If you decide to take part in this study, you will either get chemotherapy and radiation for 6-8 weeks, or you will get durvalumab immunotherapy in addition to chemotherapy and radiation for 6.5-8 weeks. After you finish your study treatment, your doctor will continue to follow you for up to 3 years. The follow-up will consist of visits to his or her office and CT scans of the bladder.
Patient must have histologically proven pure or mixed urothelial cancer of the bladder.
Patient must be ≥ 18 years of age.
Must have adequate renal function as evidenced by calculated (Cockcroft’s formula) creatinine clearance or 24 hours actual creatinine clearance ≥ 30mL/min.
Patient must have a life expectancy of at least 12 weeks, as determined by the treating physician.
Patient must not have received any previous radiation therapy to the pelvic area.
Women 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 with a negative biopsy of nodes determined to be suspicious on imaging are not eligible.
Small cell carcinoma is excluded, however other variant histologies are permitted provided a component of urothelial carcinoma is present.
Phase II Trial of Palbociclib with Fulvestrant in Individuals withHormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor
In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.
Participants will be required to come to the clinic every three weeks for evaluation and fulvestrant injections, take medication correctly, keep all appointments.
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
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).
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
PSCI 22-127 NRG-BN012: A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES
Individuals with cancer that has spread to their brain who have 1-4 lesions, or breast cancer history and may or may not have treatment and are within 8 weeks of surgery, will be randomized to either surgery first followed by radiation or radiation first followed by surgery.
Subjects are expected to come to all Radiation/Gamma Knife appointments and continue onto surgery/resection.
Known active or history of invasive non-CNSprimary cancer based on documented pathologic diagnosis within the past 3 years.
All brain metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem.
Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
Age ≥ 18
Evidence of leptomeningeal disease
Primary histology of germ cell tumor, small cell carcinoma or lymphoma
Inability to undergo MRI with contrast.
More than one brain metastasis planned for resection
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
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.
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
An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC.
At the study visits, the following procedures should happen:• Your study eligibility will be determined• There will be a review of your current medications and medical history• You will undergo a physical examination that includes measuring your height, weight, taking your vital signs, checking your heart with an electrocardiogram, and determining your ECOG performance status (a measure of your daily functional activity)• You may undergo tumor biopsy if clinically feasible according to your doctor or may be asked for a previously collected sample. You will be asked for a previously collected tumor biopsy if clinically feasible by your doctor• Blood and urine will be taken to determine the function of your liver, kidneys, and bone marrow function.• Blood samples will also be collected to assess potential changes in biological molecules in the blood such as certain proteins and pieces of DNA shed from tumor cells • You will receive a variety of imaging procedures to determine the status of your cancer throughout the study. These will include CT and PET scans, bone scans and may include other scans like X-rays and MRI scans.• On repeat visits, your doctor will ask you about any changes in the way you feel
Patients must have an ECOG performance status of 0 to 2
Patients must be adults >= 18 years of age
Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan
Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity
Patients with a history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
Patients with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
Patients who received transfusion for the sole purpose of making a subject eligible for study inclusion
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.
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.
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
PSCI 22-141 CCTG MA.39: “Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer
To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.
Women with low risk breast cancer will be randomized to either regional radiation therapy or no regional breast radiation therapy. Patients will be expected to keep all of their radiation appointment and complete all questionnaires.
Patients must have been treated by BCS or mastectomy with clear margins of excision*.
Patients with T3N0 disease are eligible.
Patients with disease limited to nodal micrometastases are eligible.
Patients must be ER ≥ 1% and HER2 negative on local testing
Patients with pT3N1 and pT4 disease
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy
Synchronous or previous contralateral invasive breast cancer.
Patients who are pregnant.
A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)
Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Telehealth Navigation for Informed Prostate Cancer Screening in Black Men
This study is being conducted to determine whether patient navigation improves informed decision making for prostate cancer screening. Participants will be offered the opportunity to discuss and address issues related to PSA testing with a patient navigator over a one month period. Surveys at the beginning and end of this period will include health knowledge, opinions on telehealth, and barriers to health care. All sessions will be conducted virtually.
Complete short on-line questionnairesComplete at least one telehealth session with the Patient Navigator
100
ages 45 to 70
spoken english language
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
E4512- A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Purpose of this study is to compare any good and bad effects of using the study drug, crizotinib after completeion of surgery and in some cases after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer.
You will need to have the following extra exams and tests to find out if you can be in the research study:•Electrocardiogram (EKG) to check your heart rhythm•Blood or urine pregnancy test, if you are a woman of child-bearing potential•Smoking status survey•ALK Fusion Status test using tissue from your previous surgery and/or biopsiesToxicity assessment will be done every 3 weeks for the first 6 weeks, then every 6 weeks for the next 12 weeks, then every 12 weeks until treatment is completed.
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE
ALK positive
Patients must have completed any prior adjuvant chemotherapy or
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III (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
DFMO for Medullo
This is a study of the drug DFMO (difluoromethylornithine) for medulloblastoma that has returned or not responded to treatment. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as MRI of your brain and spine. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.
You are 21 years old or younger
You must have no evidence of disease at this time
22-111 A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma
This study involved testing a drug for the treatment of relapsed/refractory multiple myeloma. The trial consists of three parts: the first part looks at the safety of the drug when given to patients; the second and third part looks the dose of the drug at how the drug is used through the body and how it acts on multiple myeloma.
Participants will need to attend the scheduled visits, provide medical history, blood samples, complete questionnaires, radiology exams, bone marrow aspirate and/or biopsy, and take study medication
Aged 18 years or older.
For patients in Parts 2 and 3 only: Measurable disease defined as one of the following: a)Serum M-protein ≥500 mg/dL (≥5 g/L).
During Part 1 only, patients not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (≥10%) and/or plasmacytoma (≥1 cm in diameter) detected by physical examination or imaging.
ECOG performance status of ≤2.
Patients who have received autologous SCT 60 days before first infusion of modakafusp alfa or patients who have received allogeneic SCT 6 months before first infusion.
Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Part 1: Until the MTD/OBD is defined, patients who have received daratumumab (or other investigational anti-CD38 antibody) for at least 5 months (steady state) require a 90-day wash-out period before receiving modakafusp alfa.
Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline,
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase.In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia.Induction Treatment Phase (1-3 months)•Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase.Maintenance Treatment Phase (12 months)•Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor.Long-term Follow-up Phase (48 months)•Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.•Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Phase III Study of Daratumumab/RHuPH20 + Lenalidomide or Lenalidomide in Patients with Multiple Myeloma Using MRD to Direct Therapy Duration (PSCI# 19-079) (S1803)
This study is being done to answer the following questions: 1.Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer?2.For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide (NRG-GU008) (PSCI# 20-087)
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. 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, 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 time without prostate cancer spreading compared to the usual approach. The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
The purpose of this study is to compare the use of hormone therapy and radiation therapy (usual treatment) to the use of apalutamide and abiraterone acetate with prednisone plus the usual treatment. The addition of apalutamide and abiraterone acetate with prednisone to the usual treatment could stabilize your cancer and prevent it from spreading. 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, 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 time without prostate cancer spreading compared to the usual approach.The study drugs, apalutamide and abiraterone acetate with prednisone, are already approved by the FDA for use in prostate cancer. But, most of the time abiraterone acetate with prednisone is not used until hormone drugs stop working and apalutamide is not used until hormone drugs stop working and after prostate cancer has spread. There will be about 586 people taking part in this study.
History/physical examination within 90 days prior to registration
ECOG Performance Status of 0-1 within 90 days prior to registration
Any T-stage is eligible (AJCC 8th ed)
Adequate hepatic function within 90 days prior to registration
Seizure or known condition that may pre-dispose to seizure
Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events within 6 months prior to registration
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
Patients with inflammatory bowel disease.
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
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.
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.
S1914 Randomized Phase III Atezolizumab + SBRT vs SBRT alone in high risk, early stage NSCLC (22-025)
To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.
Patients will need to keep all of their radiation treatment appointments and keep all appointments with the study doctor. Patients will be expected to complete questionnaires and have extra blood samples taken at specific time point throughout the study.
Age ≥ 18
ECOG performance status of 0 or 1 within 180 days prior to registration;
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration.
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
HIV positive with CD4 count < 200 cells/microliter
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOREARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)
The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery.This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END 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 early-stage oral cavity cancer and are having neck dissection surgery.
Age ≥ 18
Zubrod Performance Status 0-2 within 42 days prior to registration
Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
Phase III Trial of Concurrent Chemoradiotherapy with or without Atezolizumab (PSCI# 19-044)
The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.
The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy.Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients
The purpose of this study is to test the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy)
•Blood collection for laboratory tests•CT/MRI/PET/CT scans•ECG•Take study drug•Tumor assessment
Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion
Males or females, age ≥ 18 years
ECOG Performance Status/WHO Performance Status ≤ 1.
Life expectancy of > 24 months
Evidence of distant metastases at screening
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ
Presence of active infections
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
PSCI# 18-049 A PHASE II, DOUBLE-BLINDED, PLACEBO-CONTROLLED RANDOMIZED TRIAL OF SALVAGE RADIOTHERAPY WITH OR WITHOUT ENHANCED ANTI-ANDROGEN THERAPY WITH APALUTAMIDE IN RECURRENT PROSTATE CANCER
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
A Phase I/II, Multicenter, Open Label, Multi Arm Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Preliminary Activity Of Idasanutlin In Combination With Either Chemotherapy Or Venetoclax In The Treatment Of Pediatric And Young Adult Patients With Relapsed/Refractory Acute Leukemias Or Solid Tumors
A study of the safety of idasanutlin for children with solid tumors and leukemias that returned or did not respond to previous treatment.
You will be expected to take your assigned study drug combination (either idasanutlin and venetoclax or idasanutlin and chemotherapy). You will also need to come to all study visits as possible. You will need to make sure you are not in another research study, and that you will take all of the required precautions agaiinst pregnancy.
Have a solid tumors or leukemia that returned or did not respond to previous treatment
Have uncontrolled infection
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial
This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that:•Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail).•The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment.•There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
Patients will have to sign the consent form to participate in the trial
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
The purpose of this study is to see if stool or blood can be used to determine whether or not a patient has any colon polyps or colon cancer. This study will compare these biological samples (blood, urine, stool) to any colonoscopy or surgery a patient has to see if the outcome could be predicted.
Subjects with Colon Cancer or Adenoma
OR subjects undergoing colonoscopy screening
HIV/Hepatitis
Have had or are receiving chemotherapy or radiation
Have had surgery for your colon cancer
Cognitive Impairment