Search Results
KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA
Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.
The purpose of this voluntary research study is to compare any good and bad effects of using the study drug, pembrolizumab, plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk 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
A Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16 Positive Oropharyngeal Cancer (NRG-HN005) (PSCI# 20-011)
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse. This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse.This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations
P16-positive based on local site immunohistochemical tissue staining
Zubrod Performance Status of 0-1 within 14 days prior to registration
Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available
Recurrent disease
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Cancers considered to be from an oral cavity site or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resectionfor Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion inthe clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
This is a study of the drug DFMO (difluoromethylornithine) for neuroblastoma 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 CT scans and MIBG or PET scans. 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.
Completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy
Currently receiving another investigational drug
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
NRG-GU007, Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) (NCT 04037254) (PSCI# 20-104)
The purpose of this study is to compare the usual treatment alone to using the study drug niraparib plus the usual treatment. The addition of niraparib to the usual treatment could prevent your cancer from growing or 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, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.
This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.
Age is greater than or equal to 18 years old
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Adequate hematologic, renal, and hepatic function within 90 days prior to 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
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age
This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .
This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .
Must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension
ECOG performance status of 0-2
Adequate organ function as measured by the criteria
Total Bilirubin ≤ 1.5x upper limit of normal (ULN) or ≤ 3x ULN with documented Gilbert’s syndrome
Should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma
Must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication
Must have no active, uncontrolled infections
Must not have active hepatitis B or be chronic carriers of hepatitis B.
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
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
Phase II, questionnaire for “BRITE Synergy: Developing and Validating a Framework for Measuring Resilience in Low-Income Housing in the Post-Pandemic World”
This study includes the questionnaire related to "BRITE Synergy: Developing and Validating a Framework for Measuring Resilience in Low-Income Housing in the Post-Pandemic World" which has been previously submitted. The objective of this part of the research is examining the extent to which energy burden linked to the use of inefficient appliance within the context of a changing climate can be a good proxy for community resilience and if the ongoing building electrification drive.
Participants will be asked to complete an online survey via a link that will be accessed.
10 random participants will receive $20 gif cards.
Subjects must be living in the US
Living outside the US
A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)
This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.
venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin
The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
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
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)
A Phase Ib/II Study of APG-115 as a Monotherapy or in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors.Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas. To assess APG-115 as a monotherapy in patients with unresectable or metastatic melanomas and MPNST cohorts only.
If you are eligible and agree to receive the study drug combination, you will need to come to the study site at various times to have procedures done. These procedures may include collection of vital signs, blood andurine samples, electrocardiogram, physical exam, tumor biopsy, imagingscans, and x-ray. At each visit, you will be asked about your current medicines, including over-the-counter medications, and about any symptoms or side effects you might be having. You will receive the study drug orally on Days 1, 3, 5, 7, 9, 11, 13 of every 21-day cycle. Pembrolizumab is given as a 30-minute intravenous (IV – through a needle into a vein) infusion on Day 1 of every 21-day cycle.
Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy
ECOG Performance scale of 0-2
Life expectancy of equal to or greater than 3 months
Adequate bone marrow and organ functionAdequate
Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment.
Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose.
Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS.
Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC).
this is a phase II study to evaluate the safety and tolerability of 2 doses of elafibranor in participants with Primary Sclerosing Cholangitis (PSC), and its potential effect on the change in serum alkaline phosphatase (ALP) and other hepatic markers of PSC during 12 weeks of treatment in the double-blind period (DBP) compared to placebo. This will be followed by a 96-week open-label extension (OLE) period (no placebo) to assess long-term safety and maintenance of effects of elafibranor.After the first dose of the study intervention on Day 1, the participants will have study visits every 4 weeks through Week 12 of the DBP to assess efficacy and safety. In the OLE period, the study visits for each participant will occur after 4 weeks of entering the OLE, then every 12 weeks up to Week 52, followed by every 22 weeks up to Week 96 which will be the end of treatment (EOT). All participants will have a safety follow-up 4 weeks after the last dose of study intervention.
There will be 2 screening visits followed by 4 visits during the double blind/placebo part of the trial, followed by visits every 3 months for the open label part of the study. All visits will be in person. Blood will be drawn at every visit. Urine will be collected at most visits. ECG's (recording of your heart activity) will be done on a regular basis. Additional procedures include fibroscans (scan of your liver to determine liver stiffness) and ultrasound exams of your abdomen and bladder. Multiple questionnaires will be competed throughout the trial period.
Elevated ALP
percutaneous drain or bile duct stent
cholangiocarcinoma
bacterial cholangitis within 60 days
hepatic decompensation
A randomized, double blind, vehicle-controlled, multicenter Phase II study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the treatment of moderate to severe Acne vulgaris in adults with photodynamic therapy (PDT)
Moderate to Severe Acne Vulgaris: Males/Females 16 years and older. You will receive the study drug with either 1 hour or 3 hours between study drug application and illumination. The purpose of this study is to test the effectiveness and safety of the study drug, used at two different incubation times (time starting with administration of study drug until start of the red light illumination).
Subjects will attend in person visits in the Dermatology Clinical Trial Office. Your length of participation will depend on how your acne responds to the first treatment; the length of participation for 3 treatments will be approximately 25 weeks.Throughout the study at different time points Dr. Zaenglein will evaluate your acne, blood will be drawn, photos will be taken, and questionnaires will need to be completed.
Study Coordinator will discuss during phone screen.
willingness to stop topical facial treatments other than medical cleansers at least 14 days prior to receiving investigational product.
For females must use an adequate and highly effective or two effective methods of contraception throughout the study. Study coordinator will discuss.
For males- beard or other facial hair that might interfere with the study assessments unless subject agrees to be clean-shaven throughout the entire study period.
Certain medications/treatments not allowed during the study; study coordinator will discuss.
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.
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 II Trial of Eflornithine/DFMO as Maintenance Therapy for Molecular High Risk/Very High Risk and Relapsed/Refractory Medulloblastoma
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
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
A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/Refractory Solid Tumors
Neratininb for childhood cancer that has returned or is not responding to previous therapy
Cancer that has returned or is not responding to previous therapy
Has failed at least one prior therapy
PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER
This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.
Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.
Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
This study is being conducted to determine the efficacy, safety and tolerability of subcutaneous (applied under the skin) dosing of an experimental drug named ABC008 in subjects with inclusion body myositis (IBM).
Eligible subjects will be randomized into four different groups with one of two dose levels of the study drug or matching placebo. The study drug will be given by injection every eight weeks. At the safety follow-up visit, subjects will have the option to enroll in a long-term extension study.
$1137
Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures
Willing and able to comply with the requirements of the protocol, including traveling to the site for study-related assessments and SC injections, and using electronically administered diaries and questionnaires
Weight >40 and <115 kg
Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM
Any condition, e.g., severe degenerative arthritis with limited range of motion, which precludes the ability to quantitate muscle strength or perform functional assessments (e.g., mTUG,) in the Investigator’s opinion
Presence of another autoimmune or autoinflammatory disease other than indication under study
Major surgery within 12 weeks before Screening, major surgery planned during the study period, or any surgery planned during the study period
Initiation of an exercise or a physical therapy regimen within 4 weeks of Screening. Any exercise or physical therapy regimen initiated prior to the Screening Visit must have been stable for at least 4 weeks prior to Screening
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
PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.
Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy