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Glioblastoma Multiforme clinical trials

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NCT ID: NCT04608812 Terminated - Glioblastoma Clinical Trials

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection

Start date: March 2, 2021
Phase: Phase 1
Study type: Interventional

The primary goal of this Phase 1 study is to determine if a new investigational drug, OS2966, when delivered directly to the brain of adult participants with recurrent/progressive high-grade glioma (HGG) is safe and well tolerated. OS2966 is a therapeutic antibody blocking a cell surface receptor governing fundamental biological processes that allow cancer cells to grow, spread and become resistant to cancer treatment. Despite availability of new promising cancer treatments, successful treatment of HGG has been limited by the presence of the brain's protective blood brain barrier (BBB). The BBB is made up of tightly knit cells that block entry of several substances including cancer treatments. To overcome this obstacle, a technique called convection-enhanced-delivery (CED) will be utilized to deliver OS2966 directly to the site of disease. Convection-enhanced delivery involves placement of one or more catheters into the brain tumor and tumor-infiltrated brain in order to slowly pump a therapy into the tissue. To be eligible for this study participants must require surgical resection of their recurrent HGG.

NCT ID: NCT04489420 Terminated - Clinical trials for Glioblastoma Multiforme

Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM

CYNK001GBM01
Start date: October 1, 2020
Phase: Phase 1
Study type: Interventional

This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy for the systemic cohort (IV) (intravenous). The intratumoral cohort (IT) will not be giving lymphodepletion. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating recurrent glioblastoma multiforme.

NCT ID: NCT04421378 Terminated - Clinical trials for Glioblastoma Multiforme

A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

Start date: June 8, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion) and a Phase 2 randomized efficacy exploration study and will independently evaluate 3 different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or with rGBM (Arm C). - Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM participants with uMGMT - Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide (TMZ) (S-TRT) in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase (mMGMT) - Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status - Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status - Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in rGBM participants regardless of MGMT status

NCT ID: NCT04327011 Terminated - Clinical trials for Glioblastoma Multiforme

A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511

Start date: February 2011
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, continuation study to allow subjects who have previously received Toca 511 to continue to receive Toca FC and to allow for extended safety observations. Subjects will be seen on an every six week basis for 1 year or longer. Subjects who continue to receive Toca FC will receive the dose described in the "parent" protocol. If the Toca FC dose is adjusted for any reason, the serum concentration will be monitored. Gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scans will be performed as per standard of care. If the subject has recurred/progressed, repeat intracranial injection of Toca 511 followed by Toca FC treatment may be offered to consenting patients. Subjects who enter the study to continue Toca FC and subsequently discontinue Toca FC, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals. After the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years. All subjects will be followed on study for at least 5 years regardless of whether they are taking Toca FC.

NCT ID: NCT03861598 Terminated - Glioblastoma Clinical Trials

Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells

Start date: July 19, 2019
Phase: Early Phase 1
Study type: Interventional

Subjects will receive standard chemotherapy and Tumor Treated Fields (TTFields) and will also receive Carvedilol for 4 cycles of treatment. Carvedilol will start at 6.25 mg orally twice a day and be increased to 12.5 mg orally twice daily after 1 to 2 weeks if tolerated. Peripheral glioma circulating tumor cells (CTC) and brain MRI with and without contrast will be obtained at baseline, 2 cycles, and 4 cycles to determine the efficacy and direction of change of the CTC using a new assay tool. Preliminary assessment of the tolerability of Carvedilol with standard chemotherapy will also be evaluated.

NCT ID: NCT03707457 Terminated - Glioblastoma Clinical Trials

Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma

Start date: March 22, 2019
Phase: Phase 1
Study type: Interventional

This research is being done to test if it is safe to give nivolumab with targeted immunotherapy drugs for recurrent glioblastoma (GBM), a type of brain tumor. The study doctors believe that giving immunotherapy drugs that match the biomarkers in a tumor will help the immune system fight the tumor. Tumor tissue collected during surgery will be tested for certain biomarkers to determine which immunotherapy might best target the tumor. The combination immunotherapy arms include: Arm A: Nivolumab + anti-GITR Arm B: Nivolumab + IDO1 inhibitor Arm C: Nivolumab + Ipilimumab

NCT ID: NCT03705351 Terminated - Glioblastoma Clinical Trials

Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

Start date: December 2, 2019
Phase: Phase 1
Study type: Interventional

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

NCT ID: NCT03419403 Terminated - Clinical trials for Glioblastoma Multiforme

UNITE Study: Understanding New Interventions With GBM ThErapy

Start date: July 30, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).

NCT ID: NCT03363659 Terminated - Glioblastoma Clinical Trials

Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme

Start date: March 28, 2018
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03332355 Terminated - Clinical trials for Glioblastoma Multiforme

Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2

Start date: October 1, 2017
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are to determine the maximal tolerated dose (MTD) of PAC-1 in combination with temozolomide in patients with high grade glioma: glioblastoma multiforme (GBM) or anaplastic astrocytoma after progression following standard first line therapy (Component 2), by evaluation of toxicity and tolerability.