A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed With Stereotactic...
Brain MetastasesThe purpose of this study is to find out what effects, good and/or bad, stereotactic radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of giving radiation therapy to the brain in a very focused way, so that nearby parts of the brain receive very little exposure to radiation. No incisions are involved. Imaging technology is used to pinpoint the location of the tumor. In this study, the investigators are also trying to find out how the tumor and/or treatment affect brain function over time. The investigators will do this by performing a series of neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before treatment and at regular intervals after treatment.
Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma...
Melanoma and Brain MetastasesThis is a global, multi-centre, open-label, study of GSK2118436 conducted in up to 30 evaluable subjects with resectable, BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. All subjects in this study are required to have accessible extracranial metastases and are agreeable to undergo repetitive biopsies. The first cohort of 15 subjects will receive dabrafenib orally 150mg twice daily (BID) for 7 to 14 days prior to surgery (Cohort A); the second cohort of 15 subjects will receive the combination of dabrafenib 150 mg BID and trametinib 2 mg once daily for 7 to 14 days prior to surgery (Cohort B). The primary purpose of this study is to determine levels and distribution of dabrafenib, its metabolites, and trametinib (Cohort B only) in parenchymal brain metastases, extracranial metastases, and peripheral blood (plasma) within two cohorts of subjects with BRAF V600E/K mutation-positive melanoma that has metastasized to the brain. All subjects will be followed for survival and new anti-cancer therapy for a total of two years or until death or the subject wishes to withdraw from further follow-up.
Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System
Metastatic Brain TumorPrimary Brain Tumor2 moreThe NeuroBlate® System (NBS) is a minimally invasive robotic laser thermotherapy tool that is being manufactured by Monteris Medical. Since it received FDA clearance in May 2009, the NBS has been used in over 2600 procedures conducted at over 70 leading institutions across United States. This is a prospective, multi-center registry that will include data collection up to 5 years to evaluate safety, QoL, and procedural outcomes including local control failure rate, progression free survival, overall survival, and seizure freedom in up to 1,000 patients and up to 50 sites.
Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small...
Lung Carcinoma Metastatic in the BrainStage IV Lung Non-Small Cell Cancer AJCC v7This pilot phase II trial study evaluates the usefulness of the ferumoxytol steady state magnetic resonance imaging (MRI) technique for response assessment after pembrolizumab and radiation therapy in non-small cell lung cancer that has spread to the brain (brain metastases). The interactions of monoclonal antibodies such as pembrolizumab, and the body's immune system may result in an anti-tumor effect. However, it may also increase inflammation around the tumor which cannot be differentiated from true tumor growth on standard MRI. This study evaluates ferumoxytol as an MRI contrast agent to differentiate this treatment related inflammation from true tumor growth.
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis
GliomaGlioma of Brain1 moreThis protocol is designed to assess the need for seizure prophylaxis in the perioperative period for patients undergoing neurosurgical procedure (gross-total resection, sub-total resection or biopsy) for suspected diagnosis of new, recurrent or transformed glioma (WHO grade I-IV) and brain metastasis. This will be determined by observing the impact of Lacosamide (LCM), Levetiracetam (LEV), or no anti-epileptic drug (AED) on whether visits to the emergency department (ED) or hospital re-admissions occur within 30 days after procedure. A secondary endpoint will evaluate the safety and tolerability of LCM and LEV. Exploratory endpoints will evaluate admission duration for the procedure, number of post-operative provider communications (telephone, email, and additional clinic encounters, etc.), and patient risk factors associated with post-operative seizure.
MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors
Non-Small Cell Lung CancerNonsmall Cell Lung Cancer16 moreBrain metastases are the most common intracranial malignancy occurring in 20-40% of all cancers, and the presence of CNS metastases is associated with a poor prognosis. As such, the median overall survival of patients with symptomatic brain lesions is a dismal 2-3 months regardless of tumor type. Because standard chemotherapy largely does not cross the blood brain barrier at a meaningful concentration, standard treatment is limited and usually involves surgical resection and/or stereotactic radiosurgery for isolated lesions and whole brain radiation for multiple lesions. Unfortunately, the median overall survival is only improved by about 6 months with this multimodality approach2, and there is a paucity of second-line therapies to treat recurrence. Furthermore, re-resection and re-radiation are often not feasible options due to concern for increasing complications or neurotoxicity, respectively. Thus, there is a dire clinical need for additional treatment options for this patient population. Checkpoint blockade therapy, in particular PD-1 and PD-L1 inhibition, has recently shown clinical efficacy in multiple types of solid tumors. The investigators propose to study the efficacy of checkpoint blockade therapy in patients with solid tumors and refractory/recurrent brain metastases. The investigators will assess the efficacy of MEDI4736, a novel PD-L1 inhibitory monoclonal antibody, in this study.
Phase II Study of Intraventricular Methotrexate in Children With Recurrent or Progressive Malignant...
Recurrent Childhood MedulloblastomaRecurrent Childhood Ependymoma3 moreThe purpose of this research study is to test an experimental treatment method for recurrent or progressive brain tumors in children aged from 0-22 years. The use of methotrexate and chemotherapy (topotecan and cyclophosphamide) is experimental in this study. This means that their use by themselves or together has not been approved by the U.S. Food and Drug Administration for this usage.
Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine Gliomas...
Brain CancerBrain Stem Tumors1 moreThis is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients with the EGFRvIII peptide vaccine after conventional radiation.
Radiosurgery Plus Bevacizumab in Glioblastoma
GlioblastomaGliosarcoma1 moreRATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of glioblastoma by blocking blood flow to the tumor. Drugs used in chemotherapy such as irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiosurgery together with bevacizumab and irinotecan hydrochloride may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving radiosurgery together with bevacizumab and irinotecan hydrochloride works in treating patients with recurrent glioblastoma.
Magnetic Resonance Temperature Imaging & Imaging-Guided Laser Induced Thermal Therapy for Treatment...
Brain TumorThe goal of this clinical research study is to learn about a new therapy device called the Visualase® Thermal Therapy System (a device that uses a laser to kill tumor cells and is guided using magnetic resonance thermal imaging [MRTI]). The Visualase® Thermal Therapy System is used to treat metastatic brain tumors. Researchers want to find out if it is possible to use this new device in patients with metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.