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Brain Neoplasms clinical trials

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NCT ID: NCT02753790 Completed - Neoplasm Metastasis Clinical Trials

Whole Brain Radiation Using IMRT for Patients With Brain Metastases

Start date: February 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02743481 Completed - Lymphoma Clinical Trials

Early Life Exposures in Agriculture

Start date: April 14, 2016
Phase:
Study type: Observational

Background: The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and Iowa. It also included people who worked with pesticides in Iowa. They answered a questionnaire and gave data about their children born since 1975. Researchers want to link this data to public data like birth and death certificates. They want to study how early life exposures to farms are linked to cancer and other bad health outcomes. Objective: To study data to find links between early life farm exposure and negative health outcomes. Eligibility: There will be no human subjects. Design: Researchers will get public data in the two study states. This will come from things like: Birth certificates Driver s licenses Voter registration Death certificates Based on these plus the AHS data, they will create a study group. It will be called Early Life Exposure in Agriculture (ELEA). Researchers will link ELEA data to cancer data. This will identify prevalence of cancer. They will study parents answers on the AHS. The topics include farm practices and pesticide use. They will determine ELEA exposure to pesticides. Researchers will analyze the cancer and pesticide results and look for links.

NCT ID: NCT02731521 Completed - Malignant Gliomas Clinical Trials

Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

Start date: January 2014
Phase:
Study type: Observational

The Investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in isocitrate dehydrogenase (IDH) mutated gliomas and IDH wild type gliomas.

NCT ID: NCT02707549 Completed - Brain Neoplasms Clinical Trials

Fluid Therapy During Brain Tumor Resection in Children

Start date: August 2015
Phase: Phase 2
Study type: Interventional

Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. This study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.

NCT ID: NCT02677142 Completed - Brain Tumours Clinical Trials

Evaluating the Efficacy of a Group Social Skills Intervention

Start date: April 2012
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT02667587 Completed - Brain Neoplasms Clinical Trials

An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

CheckMate548
Start date: May 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

NCT ID: NCT02662725 Completed - Melanoma Clinical Trials

Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

IPI+RTS
Start date: September 2012
Phase: Phase 2
Study type: Interventional

This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker.

NCT ID: NCT02661282 Completed - Glioblastoma Clinical Trials

Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma

Start date: June 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of autologous cytomegalovirus (CMV)-specific cytotoxic T cells when given together with temozolomide and to see how well they work in treating patients with glioblastoma. Autologous CMV-specific cytotoxic T cells may stimulate the immune system to attack specific tumor cells and stop them from growing or kill them. Drugs used in chemotherapy, such as temozolomide, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving autologous CMV-specific cytotoxic T cells with temozolomide may be a better treatment for patients with glioblastoma.

NCT ID: NCT02658981 Completed - Glioblastoma Clinical Trials

Anti-LAG-3 Alone & in Combination w/ Nivolumab Treating Patients w/ Recurrent GBM (Anti-CD137 Arm Closed 10/16/18)

Start date: August 24, 2016
Phase: Phase 1
Study type: Interventional

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.)

NCT ID: NCT02656407 Completed - Brain Tumor Clinical Trials

Intraoperative Functional Ultrasound

FUSIMAGINE
Start date: February 11, 2016
Phase: N/A
Study type: Interventional

A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)). Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent. This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity. Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition. The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI. Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.