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GBM clinical trials

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NCT ID: NCT03451799 Active, not recruiting - Glioblastoma Clinical Trials

Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma

Start date: April 13, 2018
Phase: Phase 1
Study type: Interventional

Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.

NCT ID: NCT03426891 Completed - Glioblastoma Clinical Trials

Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma

Start date: March 16, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to test the safety and tolerability of the combination treatment of the investigational drugs vorinostat and pembrolizumab, in combination with chemotherapy (temozolomide), and radiotherapy. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers. However, both vorinostat and pembrolizumab are considered investigational drugs in this study because they are not approved for treatment of glioblastoma.

NCT ID: NCT03367715 Completed - GBM Clinical Trials

Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma

Start date: February 7, 2018
Phase: Phase 2
Study type: Interventional

This is a single arm, open-label, phase II trial of nivolumab, ipilimumab and short-course radiation therapy in adult patients with newly diagnosed, MGMT unmethylated GBM with the primary objective of determining the overall survival at 1 year.

NCT ID: NCT03341806 Completed - Glioblastoma Clinical Trials

Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

Start date: June 13, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to characterize the safety and tolerability of avelumab in combination with Laser Interstitial Thermal Therapy (LITT) for blood barrier disruption in patients with recurrent glioblastoma.

NCT ID: NCT03149575 Terminated - Glioblastoma Clinical Trials

VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM

STAR-3
Start date: October 27, 2017
Phase: Phase 3
Study type: Interventional

This is an adaptive design, randomized controlled, Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) or gliosarcoma (GS), previously treated with surgery (if appropriate), standard of care chemo-radiation with temozolomide, +/- adjuvant temozolomide, and bevacizumab and now has progressive disease during or after bevacizumab. A total of up to 180 eligible patients with recurrent/progressive GBM or GS will be randomized to receive either the investigational drug (VAL-083) or "Investigator's choice of salvage therapy" as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive VAL-083 at 40 mg/m2 IV on days 1, 2, and 3 of a 21-day treatment-cycle, for up to 12, 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation. Up to 60 patients will be randomized to receive "Investigator's choice of salvage therapy", limited to temozolomide, lomustine, or carboplatin, until they fulfill one of the criteria for study discontinuation. The dose level for Investigator's choice salvage therapy (temozolomide, lomustine, or carboplatin), will be in accordance with the product label or institutional guidelines. In both study arms, interval medical histories, targeted physical exams, neurologic evaluations, complete blood counts, and other laboratory and safety assessments will be performed approximately every 21-days while receiving treatment. Tumor assessments are to be performed approximately every 42 ± 7 days while remaining on study. The study is estimated to last approximately 20 months.

NCT ID: NCT03119064 Terminated - Glioblastoma Clinical Trials

BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma

329
Start date: November 30, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic temozolomide is a standard treatment option but has, at best, modest activity. The nanoliposomal irinotecan may be much more active than the parent compound irinotecan since nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I study will establish the MTD of the combination of nanoliposomal irinotecan in combination with temozolomide safety and preliminary clinical efficacy of the combination of nanoliposomal irinotecan and metronomic temozolomide.

NCT ID: NCT03050736 Active, not recruiting - Glioblastoma Clinical Trials

Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression

Start date: December 17, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in combination with a standard of care radiation regimen when used to treat newly diagnosed GBM in patients with unmethylated promoter of the methylguanine-DNA methyltransferase (uMGMT) gene. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

NCT ID: NCT03025893 Recruiting - Glioblastoma Clinical Trials

A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme

STELLAR
Start date: August 31, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule, will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic properties, inhibit gliomagenesis by inhibition of multiple kinases.

NCT ID: NCT03005132 Recruiting - GBM Clinical Trials

Integrative Analysis of Human Glioblastoma Multiforme

Start date: January 2016
Phase: N/A
Study type: Observational

Integrative analysis of GBM

NCT ID: NCT02974738 Active, not recruiting - Solid Tumor Clinical Trials

A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)

Start date: December 7, 2016
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to identify the maximum tolerated dose (MTD) of belzutifan Tablets and/or the recommended Phase 2 dose (RP2D) of belzutifan Tablets in patients with advanced solid tumors