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Glioma clinical trials

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NCT ID: NCT00727506 Active, not recruiting - Glioma Clinical Trials

BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma

Start date: July 2008
Phase: Phase 2
Study type: Interventional

Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV). Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.

NCT ID: NCT00723827 Completed - Glioblastoma Clinical Trials

Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

Start date: March 2008
Phase: N/A
Study type: Observational

The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt: - Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events); - Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction); - Adverse Event caused by misuse, abuse, or drug interactions; - Other information concerned with safety or efficacy.

NCT ID: NCT00717197 Completed - Malignant Glioma Clinical Trials

Study of Capecitabine to Treat Recurrent High Grade Gliomas

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if capecitabine is effective in the treatment of high grade gliomas that have returned after completing treatment.

NCT ID: NCT00705198 Completed - Glioma Clinical Trials

Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)

Start date: September 2006
Phase: N/A
Study type: Observational

The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

NCT ID: NCT00704080 Completed - Clinical trials for Glioblastoma Multiforme

A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas

Start date: August 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of XL765 in combination with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide maintenance dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug Administration for the following indications: 1) treatment of newly diagnosed glioblastoma multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial tumors and mixed gliomas.

NCT ID: NCT00694330 Completed - Glioma Clinical Trials

Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor

Start date: June 2008
Phase: Phase 1
Study type: Interventional

This research study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. This newly developed vaccine may stop cancer cells from growing.

NCT ID: NCT00687765 Completed - Glioblastoma Clinical Trials

Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma

Start date: July 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201 with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly diagnosed GBM and assess overall survival as the primary outcome measure. Information on each phase of the study will be listed when each phase opens for enrollment. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

NCT ID: NCT00686387 Recruiting - Glioma Clinical Trials

Establishment of a Brain and Spinal Tumor Tissue Bank

Start date: May 2008
Phase: N/A
Study type: Observational

The purpose of this study is to establish a Brain and Spinal Tumor Tissue/Specimen repository to serve as a resource for current and future scientific studies.

NCT ID: NCT00683761 Active, not recruiting - Clinical trials for Glioblastoma Multiforme

A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma

Start date: August 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.

NCT ID: NCT00681473 Completed - Low Grade Gliomas Clinical Trials

Late Effects of Proton Radiation Therapy in Patients With Low-Grade Glioma

Start date: July 2007
Phase: N/A
Study type: Interventional

In this research study, we are looking to study the side effects from the use of proton radiation in treating people with low-grade gliomas that are recommended radiation treatment. We expect response of the tumors to be the same with proton radiation as compared to standard 3D conformal radiation therapy, but also expect less side effects from radiation.