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Glioblastoma clinical trials

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NCT ID: NCT01478854 Completed - Clinical trials for Glioblastoma Multiforme

Neural Progenitor Cell Sparing Radiation Therapy Plus Temozolomide

Start date: December 27, 2011
Phase: N/A
Study type: Interventional

The long term goal of this research is to establish whether NPC sparing RT techniques improve neurocognitive outcomes compared to conventional RT for brain tumors. If the proposed study demonstrates that NPC sparing RT is not associated with increased LR in the spared regions of the brain compared to conventional RT, it will ideally serve as the foundation for a future multi-institutional randomized controlled trial comparing neurocognitive outcomes in patients treated with NPC-sparing RT versus conventional radiation therapy.

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: NCT01473901 Completed - Glioblastoma Clinical Trials

A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

Start date: December 30, 2011
Phase: Phase 1
Study type: Interventional

This clinical study will assess the doses of BKM120 appropriate for patients with newly diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.

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: NCT01466686 Completed - High Grade Glioma Clinical Trials

Low Dose Radiation Therapy for Glioblastoma Multiforme

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

To evaluate the safety and effectiveness of low dose rate radiation therapy plus temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.

NCT ID: NCT01454596 Completed - Glioblastoma Clinical Trials

CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII

Start date: May 16, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with gliomas that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient's white blood cells with a retrovirus that has the gene for epidermal growth factor receptor (EGFR) vIII incorporated in the retrovirus. Objective: The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-EGFRvIII cells) are a safe and effective treatment for advanced gliomas. Eligibility: - Adults age 18-70 with malignant glioma expressing the EGFRvIII molecule. Design: Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-EGFRvIII cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-EGFRvIII cells, and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans every month for the first year, and then every 1-2 months as long as their tumors are shrinking. Follow up visits will take up to 2 days.

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%).