View clinical trials related to Glioblastoma.
Filter by:Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month median survival, in the range of the comparable patients in the RPA class V from the EORTC study (Miramanoff, 2006). Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully published in J Clin Oncol, 2007) a 57 % unexpected response rate using a bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This unusual high response rate, sometimes with major and sustained responses, was confirmed by a cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France, to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM. The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the Duke University. We believe that an ambitious comparison of the bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a fascinating challenge to improve the treatment of this awful disease. The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant and adjuvant treatment of chemoradiation with temozolomide for naive unresectable glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide'' has been successfully granted by INCA (Institut National du Fancer, France) through its research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of this program is now starting .
This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a standard therapy for patients with HIV and the safety of 1250 mg BID NFV is well-established. Case studies have also reported that HIV patients have received radiotherapy for cancer, while on 1250 mg BID NFV. This is the first trial of oral NFV and chemoradiotherapy for GBM patients. Although unacceptable toxicity is unlikely, two NFV dose levels (625, and 1250 mg BID) will be evaluated in a cohort escalation design of 3-6 subjects. At the MTD, 19 additional subjects will be enrolled to generate pilot data on radiographic response and to evaluate further toxicity. A maximum of 31 subjects will be enrolled on the trial.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with temsirolimus or temozolomide in treating patients with glioblastoma. PURPOSE: This randomized phase II trial is studying giving radiation therapy together with temsirolimus to see how well it works compared with giving radiation therapy together with temozolomide in treating patients with newly diagnosed glioblastoma.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving bevacizumab together with temozolomide and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab together with temozolomide and external beam radiation therapy works when given as first-line therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
The purpose of this study is to assess the efficacy, of treating patients with recurrent glioblastoma using Gamma-Knife Radiosurgery (GKS) to target a tumor volume defined by a combination of gadolinium enhancement and magnetic resonance spectroscopy (MRS). This is a single center, Phase II trial. A total of 40 glioblastoma patients will be enrolled into the primary arm of the trial. In addition, a minimum of 10 patients with recurrent anaplastic (grade III) gliomas and a minimum of 10 patients with recurrent low-grade (grade II) gliomas will be enrolled into exploratory arms. The investigators hypothesize that the use of a combination of gadolinium enhancement and elevated Cho:NAA ratio via MRS to determine the treatment target volume for Gamma Knife may be an effective way to treat focally-recurrent glioblastoma.
1. Primary outcome measure: a.Evaluation of the treatment impact on progression-free survival. 2. Secondary outcome measures: 1. Safety evaluation. - Direct effects attributable cell obtaining and administration. - Adverse events during treatment. - Neurological deterioration quantified using the NIH Stroke Scale. - Autoimmune phenomena. 2. Evaluation of impact on other efficiency clinical parameters. - Overall survival. - Quality of life measured with EORTC questionnaire. 3. Study of specific immune response and correlates with clinical outcome. - Delayed hypersensitivity. - Humoral response to autologous tumor cells/tumoral lysate. - Cellular response (proliferation, cytokine production, specific cytotoxicity). 4. Cell line characterization and correlate the final product with clinical efficacy. - Phenotypic studies.
This is a phase II study of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and topotecan in grade IV malignant glioma patients.
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bortezomib together with temozolomide and radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started. PURPOSE: This phase II trial is studying the side effects and how well bortezomib works when given together with temozolomide and regional radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
Background: - Growth of new blood vessels (angiogenesis) provides many tumors, including brain tumors, with needed nutrients and oxygen for cancer cells to survive. One possible treatment for different kinds of cancer involves treatment with drugs that slow or stop angiogenesis and prevent further tumor growth. - Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses. - Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy. Objective: - To determine the safety and effectiveness of vandetanib and carboplatin, given together or sequentially, against recurrent high-grade gliomas. Eligibility: - Adults diagnosed with a malignant glioma who have received standard treatments that no longer appear to be effective. Design: - Patients will be assigned to one of two groups. Group 1 patients (combination group) will receive oral vandetanib for 28 days and intravenous (IV) carboplatin (once at the beginning of the 28-day cycle). Group 2 patients (sequential group) will receive IV carboplatin alone (once at the beginning of the 28-day cycle) and then oral vandetanib (300 mg daily) for 28 days if the tumor grows or the patient develops unacceptable carboplatin toxicity. - Treatment will continue in 28-day cycles for 1 year for both groups. - Patients will undergo a number of tests and procedures during the treatment cycle, including physical examinations, routine laboratory tests, electrocardiograms, and magnetic resonance imaging (MRI) scans - At the end of 1 year of treatment, patients will be reevaluated for possible continuation of drug therapy.
The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.