Active clinical trials for "Brain Neoplasms"

The purpose of this study is to try to determine the maximum safe dose of afatinib that can be administered to people with brain cancer. Other purposes of this study are to: find out what effects (good and bad) afatinib has; see how much drug gets into the body by collecting blood and cerebrospinal fluid for use in pharmacokinetic (PK) studies; learn more about how afatinib might affect the growth of cancer cells; look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug).

This phase I trial studies the safety and best dose of anti-LAG-3 (anti-LAG-3 monoclonal antibody BMS-986016) or urelumab alone and in combination with nivolumab in treating patients with glioblastoma that has returned (recurrent). Anti-LAG-3 monoclonal antibody BMS-986016, urelumab, and nivolumab are antibodies (a type of protein) that may stimulate the cells in the immune system to attack tumor cells. It is not yet known whether anti-LAG-3 monoclonal antibody BMS-986016 or urelumab alone or in combination with nivolumab may kill more tumor cells. (The Anti-CD137 antibody (BMS-663513 - urelumab) treatment arm closed by BMS on 10/16/18 due to closure of BMS Urelumab development program. Subjects currently on treatment may continue.)

Some cancers can spread, or metastasize, to the brain. When they do, treatment often involves surgery and/or radiation. Optimal treatment of brain metastases would maximize disease control and minimize toxicity (or side effects), and improve the quality of life of patients. A common type of radiation used for brain metastases is called whole brain radiation, which treats not just the cancer that can be seen on scans (i.e., gross disease), but the smaller sites of cancer that may not be visible (i.e. subclinical disease). Fractionation is used to describe repetitive treatments in which small doses (fractions) of a total planned dose are given at separate clinic visits. The most common dosing regimen is 30 Gray (Gy), using 3 Gy per fraction over 10 fractions. Previous studies have suggested that using intensity modulated radiation therapy (IMRT) may be a safer way to deliver higher doses to gross disease and lower doses to the rest of the brain that may contain subclinical disease. This approach may spare the rest of the brain from radiation complications and side effects. The goal of this study is to determine whether using IMRT to treat brain metastases is more effective than current standard whole brain radiation in controlling gross disease and whether patient quality of life and hair loss is improved compared to previous studies using whole brain radiation.

The effect of nivolumab on symptomatic brain metastases is currently unknown. This phase 2 clinical trial will be the first to evaluate this intracranial effect in humans, with the aim to give these patients the possibility to be treated with anti-PD-1. Besides the objective response rate, long term benefits in this patient category will be evaluated by measuring survival in terms of progression free survival and overall survival. Furthermore safety and tolerability of administration of this drug in patients with symptomatic brain metastases will be studied, as this is the first study for nivolumab in this specific patient category.

The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS <70.

Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase II study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified oncolytic adenovirus, when delivered directly into the tumor followed by the administration of intravenous pembrolizumab (an immune checkpoint inhibitor) given every 3 weeks for up to 2 years or until disease progression. Funding Source-FDA OOPD

Brain Tumour (BT) survivors struggle with disabling physical, emotional, cognitive and psychosocial sequelae. Unfortunately, to-date there has been very limited research into rehabilitative interventions for this population. With 55,000 BT survivors in Canada alone1, access to effective, evidence-based rehabilitative treatment that would improve BT survivors' quality of life (QOL) and capacity to cope is a necessity. Mindfulness-Based Therapy's (MBTs) are emerging as a potential treatment to address this need. MBTs are group-based psychological treatments for coping with illness or disability, with the goal of improving psychological wellbeing. Recent studies have begun to suggest a role for MBTs in addressing symptom burden and QOL in the acquired brain injury (ABI) population, a heterogeneous population that includes survivors of stroke and traumatic brain injury, as well as BT survivors. High quality research including within-subject controlled trials, are needed to demonstrate whether MBTs can provide efficacious, accessible and cost-effective treatment to improve the lives of BT survivors.

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.

Background: Zotiraciclib (TG02) is an investigational drug that penetrates the blood-brain barrier and might treat brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors. Objective: To find out if Zotiraciclib (TG02) is safe, and to find out if it in combination with TMZ is as effective as TMZ alone in people with brain tumors. Eligibility: People ages 18 and older with a brain tumor that has progressed after standard treatment Design: In phase I part, the Bayesian optimal interval (BOIN) design will be used to find the maximum tolerated dose (MTD) of Zotiraciclib (TG02) for Arm 1 (dose dense TMZ) and Arm 2 (metronomic TMZ) independently. Then a randomized cohort expansion compared progression free survival at 4 months (PFS4) of the two arms for an efficient determination of a TMZ schedule to combine with Zotiraciclib at MTD. In Phase II part, a Bayesian design based on posterior probability will be used to monitor efficacy. Participants will be screened with: Medical history Physical exam Blood and urine tests Magnetic resonance imaging (MRI) of the brain if they have not had one in 14 days Heart test Tissue sample from prior surgeries Participants will take Zotiraciclib (TG02) plus TMZ by mouth in 28-day cycles. Some will take TMZ for 7 days on and 7 days off. Others will take it every day. They will all take Zotiraciclib (TG02) three days before Cycle 1, and then on four days during every cycle. They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after each Zotiraciclib (TG02) dose. They will all keep a diary of when they take the drugs and their symptoms. Participants will have study visits. These include: Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests every 4 weeks Blood tests every 2 weeks Participants will continue treatment until their disease gets worse or they have intolerable side effects. Participants will also be enrolled in another protocol to test molecular markers for their brain tumor.

This research study is studying a novel drug called ALRN-6924 as a possible treatment for resistant (refractory) solid tumor, brain tumor, lymphoma or leukemia. The drugs involved in this study are: ALRN-6924 Cytarabine (for patients with leukemia only)