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Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas | Clinical Trials | Clareo Health

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Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas

A Phase II Trial of Talampanel in Patients With Recurrent High-Grade Gliomas.

NCT00062504•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.

Detailed Description

To determine the efficacy of Talampanel in patients with recurrent malignant glioma as measured by 6-month progression survival, as well as to obtain preliminary information regarding the spectrum of toxicities of the drug among this patient population.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Inclusion
•1. Patients with histologically proven intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).
•2. Patients must have unequivocal evidence for tumor progression by MRI or CT scan. This scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days.
•3. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
•1. They have recovered from the effects of surgery.
•2. Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done:
•* no later than 96 hours in the immediate post-operative period or
•* at least 4 weeks post-operatively, and
•* within 14 days of registration, and
•* on a steroid dosage that has been stable for at least 5 days.
+11 more criteria

Exclusion Criteria

•1. Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases are ineligible that would significantly increase the risk of using talampanel.
•2. No concurrent use of other standard chemotherapeutics or investigative agents.
•3. Patients known to have an active, life-threatening malignancy.

Key Dates

Start Date

July 1, 2003

Primary Completion Date

January 1, 2006

Completion Date

April 1, 2006

Last Updated

May 23, 2011

Enrollment

ACTUAL participants

Conditions

Glioblastoma MultiformeAnaplastic AstrocytomaAnaplastic OligodendrogliomaAnaplastic Mixed Oligoastrocytoma

Interventions

Talampanel

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas

Inclusion Criteria

Exclusion Criteria

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