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Dasatinib Plus Radiation Therapy/Temozolomide in Newly-Diagnosed Glioblastoma
Phase I: Primary Objectives: -To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m^2/day in patients with newly-diagnosed glioblastoma (GBM). Secondary Objectives: - To characterize the safety profile of dasatinib (Sprycel) in combination with radiotherapy (RT) and concomitant TMZ in patients with newly-diagnosed GBM. - To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant TMZ in patients with glioblastoma after RT. STUDY DID NOT PROGRESS TO PHASE II PORTION. Phase II: Primary Objectives: -To determine the...
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Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated. The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose. The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of...
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Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
DC vaccine manufactured and partially matured using our standard operating procedures, developed in collaboration with the HGG Immuno Group, then administered through imiquimod treated skin will be safe and feasible in children with refractory brain tumors. This will result in anti-tumor immunity that will prolong survival of subjects treated and results will be consistent with the outcomes found for subjects treated by HGG Immuno Group investigators. Study treatment will correlate with laboratory evidence of immune activation. Correlative studies will also reveal targets in the immune system which can be exploited to improve response for patients on successor trials.
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Derivation of Tumor Specific Hybridomas
This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.
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Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas
enroll patients with histologically confirmed high-grade gliomas to evaluate the ability of regadenoson to transiently disrupt a relatively intact blood-brain barrier (BBB). determine the best dose of regadenoson to disrupt the BBB and allow for enhanced penetration of gadolinium during MRI.
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Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata together with standard treatment is more effective than standard treatment alone in treating high-grade gliomas. PURPOSE: This randomized phase II trial is the study of a combination of complementary and alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The central hypothesis of this application is that a herbal preparation that inhibits 5-LO activity, will produce measurable...
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Dietary Methionine Restriction Plus Temozolomide for Recurrent GBM
Objectives: 1. To determine the safety, tolerability and efficacy of dietary methionine restriction for 7 days alternating with Temodar® (Temozolomide) given once a day for seven days and this repeated for up to one year in the treatment of patients with recurrent and/or progressive glioblastoma. 2. To determine the short- and long-term toxicity of dietary methionine restriction combined with Temodar® in glioblastoma patients. 3. To measure and correlate patients' tumor responses and progression-free survival with: serum methionine and peripheral blood lymphocyte methylation levels. In any patient undergoing surgery, to measure tumor...
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Discerning Pseudoprogression vs True Tumor Growth in GBMs
One-third of all primary brain tumors are astrocytomas, the most common type of glioma. Grade 4 astrocytomas, more commonly known as glioblastomas (GBMs), represent about 50% of all gliomas (annual incidence of over 3 per 100,000) and are associated with high mortality rates and median patient survival of just 12-15 months post-diagnosis. Treatment response is assessed by measuring post-treatment tumor size on contrast-enhanced magnetic resonance images (MRI). However, radiation and chemotherapy cause inflammatory and necrotic changes which, like actual tumor progression itself, demonstrate contrast enhancement on the first post-treatment MRI scan. This enhancement eventually...
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Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme
One of Disulfiram antitumor effects suggested in preclinical studies is MGMT (methyl-guanine-methyl-transferase) inhibition. Disulfiram MGMT inhibitory effect is enhanced by addition of Copper. This study evaluates the impact of Disulfiram (DSF) + Copper (Cu) combination when added to standard Temozolomide in the treatment of unmethylated Glioblastoma Multiforme (GBM) patients.
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DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma
Patients with first or second recurrence of GBM will be treated with stereotactic injection of the oncolytic virus DNX-2440.
