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Glioblastoma Multiforme clinical trials

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NCT ID: NCT01478178 Completed - Glioblastoma Clinical Trials

Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma

Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

NCT ID: NCT01475006 Completed - Clinical trials for Glioblastoma Multiforme

AMG 595 First-in-Human in Recurrent Gliomas

Start date: February 2012
Phase: Phase 1
Study type: Interventional

This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA). The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of AMG 595, and also to evaluate the objective response rate in subjects receiving AMG 595. This study will be conducted in two parts. Part 1 will explore doses of AMG 595 in subjects with recurrent GBM and/or AA. Part 2 (dose expansion) will examine the MTD established in Part 1 in subjects with recurrent GBM.

NCT ID: NCT01474239 Completed - Clinical trials for Glioblastoma Multiforme

A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

Start date: November 2011
Phase: Phase 2
Study type: Interventional

This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.

NCT ID: NCT01470794 Completed - Clinical trials for Glioblastoma Multiforme

Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor

Start date: February 2012
Phase: Phase 1
Study type: Interventional

This is a multicenter study evaluating the safety and tolerability of increasing doses of Toca 511, a retroviral replicating vector, injected into the resection cavity of patients with Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Approximately 6 weeks after injection of Toca 511, patients will begin an oral courses of Toca FC, an antifungal agent. These one week courses of Toca FC will be repeated during the approximately 30 week study. Two separate cohorts of patients treated with Toca 511 and Toca FC will also be evaluated with either of the following standard treatments for glioma: lomustine or bevacizumab. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.

NCT ID: NCT01468324 Completed - Clinical trials for Glioblastoma Multiforme

AZD7451 for Recurrent Gliomas

Start date: October 5, 2011
Phase: Phase 1
Study type: Interventional

Background: - AZD7451 is a drug that may help interfere with brain tumor cell growth. It can prevent glioma cells from entering into normal brain tissue, and slow or stop the growth of additional tumors. Researchers want to see if AZD7451 is effective against gliomas that have not responded to surgery, radiation, or chemotherapy. Objectives: - To see if AZD7451 is a safe and effective treatment for gliomas that have not responded to standard treatments. Eligibility: - Individuals at least 18 years of age who have gliomas that have not responded to standard treatments. Design: - Participants will be screened with a physical exam, medical history, blood and urine tests, heart function tests, an eye exam, and imaging studies. - Participants will take AZD7451 daily by mouth for 28-day cycles of treatment. - Participants will keep a medication diary and record any side effects. Treatment will be monitored with frequent blood tests and imaging studies. - Treatment will continue as long as there are no serious side effects and the tumor does not start growing again....

NCT ID: NCT01450449 Completed - Clinical trials for Glioblastoma Multiforme

Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme

Start date: February 2009
Phase: Phase 3
Study type: Interventional

This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection. This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).

NCT ID: NCT01435395 Completed - Clinical trials for Glioblastoma Multiforme

Trial of Temozolomide, Bevacizumab Plus Bortezomib for Recurrent Glioblastoma Multiforme

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

This is a single-center (Emory University), open-label, single arm, phase I study to assess safety and toxicity of bortezomib in combination with bevacizumab and escalating doses of temozolomide for patients with recurrent glioblastoma multiforme. Patients requiring anti-epileptic medications will have to be at least 10 days off EIAEDs. Only non-EIAEDs are accepted.

NCT ID: NCT01402063 Completed - Clinical trials for Glioblastoma Multiforme

PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

Start date: September 2011
Phase: Phase 2
Study type: Interventional

To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

NCT ID: NCT01353625 Completed - Prostate Cancer Clinical Trials

Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

Start date: April 25, 2011
Phase: Phase 1
Study type: Interventional

The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

NCT ID: NCT01349660 Completed - Clinical trials for Glioblastoma Multiforme

Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme

Start date: December 2011
Phase: Phase 1/Phase 2
Study type: Interventional

In this phase I/II study,investigators are evaluating the feasibility and efficacy of the combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120 dose to be administered with a standard dose of bevacizumab will be determined in patients with refractory solid tumors. Although it is unlikely that the concurrent administration of bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will be performed on all patients treated during the Phase II portion of the study. Assuming this combination is feasible, the Phase II portion of the study will proceed, using the doses determined in the Phase I portion. In the phase II portion, eligible patients will be limited to those with recurrent/progressive GBM following 1st line combined modality therapy.