Active clinical trials for "Brain Neoplasms"

Tumours affecting the brain are a very heterogeneous group of diseases. Accordingly, treatment strategies vary widely depending on child's age, tumour location, its resectability and histology. As a group, however, the survival rate of childhood brain tumors has improved in recent years, resulting in an increased number of survivors returning to school and reintegrating into their communities. Survival for many of them, however, has also come with severe costs such as neurocognitive and academic difficulties. Cognitive rehabilitation strategies to address these deficits have been a major focus of recent research. Evidence is now also mounting for social competence deficits among this population which may persist into late adolescence and adulthood, thereby negatively affecting long-term survivorship. Thus, there is an urgency to identify psychosocial interventions, such as social skills programs, that can reduce the social competence deficits in childhood brain tumor survivors and, therefore, modify the course of these outcomes to ensure that survivors thrive and become productive members of society. To date, no rigorous social skills intervention trials have been undertaken to address the social difficulties of these survivors. The current proposal is the first study that aims to address this gap by evaluating the efficacy of an innovative, manualized, social skills intervention program developed for this population using a multi-centre Randomized Control Trial (RCT).

Background: The aim of the study was to assess the safety and effectiveness of stereotactic brain tumour biopsy (STx biopsy) guided by low-field intraoperative MRI (iMRI) in comparison with its frameless classic analogue based on a prospective randomized trial. Patients are prospectively randomized into a low-field iMRI group and a control group that undergo a frameless STx biopsy. The primary endpoints of the analysis are: postoperative complication rate and diagnostic yield, and the secondary endpoints: length of hospital stay and duration of operation.

The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.

In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies.

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.

The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and extent of absorption of Temozolomide after the administration of the study product (Dralitem®, Monte Verde S.A.) and the reference product (Temodal®, Schering Plough) in primary Central Nervous System patients.

The goal of this clinical research study is to establish the maximum tolerated dose (MTD) of direct administration of methotrexate into the fourth ventricle of the brain in patients with recurrent malignant brain tumors including medulloblastoma, primitive neuroectodermal tumors (PNET), atypical teratoid/rhabdoid tumors (AT/RT), and ependymoma. Methotrexate is designed to block cancer cells from dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.

This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose can be modified by the physician based on patient reported tolerability. Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination (H&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of seizure history, patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of 16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking 6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel. Patients will be considered off treatment at the end of week 20, once perampanel has cleared their system. Patients will then be monitored through Week 24. Patients will continue to take their original AED regimen after they stop perampanel. If seizure control is achieved during the maintenance period or if seizures occur during the tapering period, patients can be continued on perampanel per the discretion of the treating physician. In this instance, perampanel will be prescribed by the treating physician and not provided within the confines of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will be given a log to record the number of seizures that occur. Research team members will regularly contact patients for reminders and reports from the log. Safety will be assessed with the following laboratory evaluations: complete blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity assessment.

Patients with brain metastases with expected life expectancy of 3-6 months are typically treated with radiotherapy to the whole brain giving a dose of 20 Gy over a 5 day period. This study will compare this with volumetric modulated arc therapy (VMAT) which is capable of delivering 15 Gy in one single session to identified disease within the brain but sparing the normal surrounding brain tissue. Primarily the study will assess whether it is possible to recruit sufficient patient numbers to a trial of this type. It will also compare effectiveness, side effects and quality of life between the two treatment methods.

The purpose of this study is to try to determine the maximum safe dose of dexanabinol that can be administered to people with brain cancer. Other purposes of this study are to: find out what effects (good and bad) dexanabinol 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 dexanabinol 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).