A PHASE II RANDOMIZED OPEN LABEL MULTI-CENTER STUDY OF THE EFFECTS OF ELCTRONIC CIGARETTES ON SMOKING HARM REDUCTION IN CIGARETTE SMOKERS WITH SERIOUS MENTAL ILLNESS.
This study will compare the feasibility and preliminary efficacy of telehealth motivational counseling + e-cigarettes versus telehealth motivational counseling + combination Nicotine replacement therapy (NRT; patch and lozenge) on reduction of cigarettes per day (CPD) and health outcomes among smokers diagnosed with Serious Mental Illness (SMI).
A Phase II Single-Arm Study of Craniospinal Irradiation with Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients with Leptomeningeal Metastasis
This study is a non-randomized phase II single-institution trial in which patients who consent to the trial will be treated with linac based VMAT CSI. The primary objective is to determine if linac based VMAT CSI for leptomeningeal metastases improves CNS progression free survival compared to historical control treated with IFRT. The investigators include doctors with expertise in treating leptomeningeal metastases both with radiation and systemic therapy.
A Phase II Study of DRP-104 a glutamine antagonist in patients with NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer and Gastroesophageal Cancer
This is a Phase 2 study testing a new medicine called DRP-104 (a glutamine antagonist) in patients with non-small cell lung cancer (NSCLC). These patients have changes or mutations in genes called NFE2L2 orKEAP1 and this makes their cancer harder to treat with chemotherapy and immunotherapy.The medicine DRP-104 works by blocking something called glutamine, which the cancer cells need to grow. This study will use a two step process to see if the medicine works well in the first group, before allowing other patients to join. In step one, patients will be given DRP-104 two times a week with at least three days betweeneach treatment, with no rest period between cycles (continuous schedule). If the results are promising and show this medicine is shrinking the tumors or stopping them from growing, more patients will be added in step two tocontinue testing the drug. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer isresponding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.
A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
This is a study that looks at whether it's safe to treat patients with bladder cancer who have certain gene changes (called DDR gene alterations) in their tumor. These patients have had a procedurecalled TURBT (a way to remove part of the tumor) before treatment. They will get chemotherapy with gemcitabine and cisplatin. The study will check if the treatment works well by looking at how many patients are still cancer-free three years after they start treatment. If more than 80% of the patients are cancer-free at that time, the treatment will be considered safe. The patients will also be watched for five years to see how many stay cancer-free. If patients' tumors do not have these gene changes, or if the tumor shrinks but not enough, they will have their bladder removed (called cystectomy) and will be followed for five years to see if the cancercomes back or if they survive longer. If patients who could have had bladder-preserving treatment end up having their bladder removed, they will also be watched for five years to see how they do.
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)
Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer (EBC). Secondary Objectives:To estimate distant metastasis-free survivalTo estimate overall survival (OS).To evaluate safety and tolerabilityTo identify predictors of loco-regional recurrence.
A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination with Ipilimumab Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination with Ipilimumab, Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas
This is a phase II study, testing if lowering the dose of standard radiotherapy (RT) after standard chemotherapy medicines (Carboplatin & Etoposide) works well with fewer long-term side effects in treating children with brain cancer (central nervous system germinomas). All patients will first receive chemotherapy medicines. The patients will have brain and spine scans taken to see how the chemotherapy medicine is changing their tumor size. Doctors will examine these results and decide if the patient will receive radiotherapy and the dose of radiotherapy or if the patient will go for surgery before receiving the radiotherapy. The study team will collect blood samples from all the patients to see how their bodies handle the medicines and how long they stay cancer-free before recurrence. The study team will monitor each patient throughout the study to see if they are doing well and check for any discomfort and side effects.
A PHASE II TRIAL EVALUATING THE SAFETY AND EFFICACY OF MR-LINAC- GUIDED RADIOTHERAPY AS SALVAGE TREATMENT AFTER EXTERNAL BEAM RADIOTHERAPY RECURRENCE (TUMORNATOR II)
This Phase 2 study is testing how using a special imaging technique called the Elekta Unity MR-linac system can be safe and effective for patients with prostate cancer that has not spread to other parts of the body after previous treatment with radiotherapy. Patients will have special scans taken before the study treatment to help the study team determine the treatment planning and doses. All patients will then be treated using an MR-guided approach on the Elekta Unity MR-linac system. The study team will collect tissue samples from all patients after treatment to see how the treatment is changing the tumor. All patients will have special scans taken and the study doctor will examine them to see how the patients are doing. All patients will be closely monitored for side effects and safety and followed every 6 months for up to 2 years after their treatment.
A Phase II/III Multicenter Randomized Double-Blind Placebo-Controlled Two-Part Adaptive Design Platform Trial of Investigational Treatments for Primary Prevention of Disease Progression in Dominantly Inherited Alzheimer s Disease
Remternetug is an investigational drug, currently being studied to treat Alzheimer's Disease (AD).The purpose of this study is to determine if remternetug has favorable effects that may prevent or reduce the AD disease in the brain and prevent or delay AD symptoms, participants will have brain scans, blood and spinal fluid collected (for biomarkers, the tests that indicate progress of disease and response to study treatment), and tests of memory and thinking. This study will consist of 2 stages, which could last up to 9 years and will involve about 50 visits (30 visits in Stage 1, 20 visits in Stage 2).
A phase II/III Study of Paclitaxel/Carboplatin alone or Combined with either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-zzfx (PHESGO) in HER2 Positive Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
This study is being done to answer the following question: Can we lower the chance of your endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs?