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Glioblastoma Multiforme clinical trials

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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: NCT02945826 Recruiting - Clinical trials for Glioblastoma Multiforme

uPAR-PET/MRI in Glioblastoma Multiforme

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.

NCT ID: NCT02939378 Recruiting - Clinical trials for Glioblastoma Multiforme

Ketogenic Diet Adjunctive to Salvage Chemotherapy for Recurrent Glioblastoma:a Pilot Study

KGDinrGBM
Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro. Therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.

NCT ID: NCT02937844 Recruiting - Clinical trials for Glioblastoma Multiforme

Pilot Study of Autologous Chimeric Switch Receptor Modified T Cells in Recurrent Glioblastoma Multiforme

Start date: July 2016
Phase: Phase 1
Study type: Interventional

CAR T cell immunotherapy has achieved great success in CD19+ B-cell malignancies. Whether this new generation of cell-based immunotherapy can be applied to solid tumors remain to be investigated, partly due to hostile immune-suppressive tumor microenvironment which favors tumor growth but not immune system. Signaling pathway of programmed death 1 (PD-1) and its ligand PD-L1 plays an important role in suppressing immune response against tumors. PD-L1 is over-expressed in 88% of glioblastoma. We constructed a chimeric switch receptor (CSR) containing the extracellular domain of PD1 fused to the transmembrane and cytoplasmic domain of the costimulatory molecule CD28. CSR modified T cells are able to recognize PD-L1-expressing tumor cells and transduce signals to activate T cells, which results in tumor killing. A truncated EGFR (tEGFR) which lacks of the ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CSR vector and is used for in vivo tracking and ablation of CSR T cells when necessary. This pilot study is to determine the safety and efficacy of autologous CSR T cells in patients with recurrent glioblastoma.

NCT ID: NCT02928575 Recruiting - Clinical trials for Glioblastoma Multiforme

Combining Sunitinib, Temozolomide and Radiation to Treat Patients Diagnosed With Glioblastoma

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a combination of Sunitinib, Temozolomide and Radiation Therapy would be effective in the treatment of newly diagnosed Glioblastoma patients harboring tumors with unmethylated MGMT promoter.

NCT ID: NCT02844062 Recruiting - Clinical trials for Glioblastoma Multiforme

Pilot Study of Autologous Anti-EGFRvIII CAR T Cells in Recurrent Glioblastoma Multiforme

Start date: July 2016
Phase: Phase 1
Study type: Interventional

Chimeric antigen receptor (CAR)-modified T cells can mediate long-term durable remissions in recurrent or refractory CD19+ B cell malignancies, and are a promising therapy to treat glioblastoma, which is the most dangerous and aggressive form of brain cancer. EGFRvIII mutation (epidermal growth factor receptor variant III, EGFRvIII) is the results of tumor specific gene rearrangement naturally happened in about 30% of glioblastoma patients and produces a mutated protein with neo-antigen that is tumor specific and is not expressed in normal human tissues. Therefore, EGFRvIII is an attractive target for CAR T cell therapy. We have constructed a lentiviral vector that contains a chimeric antigen receptor that recognizes the EGFRvIII tumor antigen. A truncated EGFR (tEGFR) which lacks of the ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CAR vector and is used for in vivo tracking and ablation of CAR T cells in necessary. This pilot study is to determine the safety and efficacy of autologous anti-EGFRvIII CAR T cells in patients with recurrent glioblastoma.

NCT ID: NCT02704858 Recruiting - Clinical trials for Glioblastoma Multiforme

Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma

Start date: April 8, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This multi-site, Phase 1/2a clinical trial is an open label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with radiographically-confirmed progression of Grade IV glioma or recurrent primary or secondary Grade IV glioma or patients with progressed or recurrent Grade III glioma. The study will have two phases, Phase 1 and Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the maximum tolerated dose (MTD) for Phase 2a. Fifteen (15) patients were enrolled into the Phase I portion of the clinical trial. The MTD for NEO100 was not reached in humans. As a result the NEO100 dose for Cohort 4 (288 mg/dose - 1152 mg/day) was carried into the Phase 2a portion of the clinical trial. Four (4) patients were enrolled into this study prior to implementation of implementation of version 10 of the clinical trial restricting the Phase 2a population to patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations or progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. None of the four (4) patients expressed IDH1 mutations. There will be 28 patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations or progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations enrolled in Phase 2a of the clinical trial. Prior to implementing v10 of this protocol, four (4) patients were enrolled. These patients met the inclusion/exclusion criteria for v9 of the protocol and had wild type IDH1 status. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycle up to six treatment cycles until disease progression or death, whichever occurs first. At the completion of cycle six, patients will be given the option to continue receiving compassionate use treatment cycles.

NCT ID: NCT02663440 Recruiting - Clinical trials for Glioblastoma Multiforme

Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme

Start date: January 2016
Phase: Phase 2
Study type: Interventional

Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme.

NCT ID: NCT02331498 Recruiting - Clinical trials for Glioblastoma Multiforme

Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

PAZOGLIO
Start date: June 2015
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I/II study of pazopanib in combination with temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)

NCT ID: NCT02285959 Recruiting - Clinical trials for Glioblastoma Multiforme

Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme

Start date: June 2014
Phase: Phase 1
Study type: Interventional

The high-grade malignant brain tumor glioblastoma multiforme (GBM) comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival durations of only 9-12 months for GBM. Initial therapy consists of surgical resection, external beam radiation or both. Currently, all patients experience a recurrence after this first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the concentration of drug delivered to the brain while sparing the body of systemic side effects. This technique threads a tiny catheter through the patient's femoral artery in the leg, up through the body and neck and into the brain. Once the catheter reaches the brain, chemotherapy is released to the blood vessels that feed the tumor.