Safety and Efficacy of Talampanel in Glioblastoma Multiforme

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Glioblastoma Multiforme

Treatments: Radiation: Radiation Therapy (RT) 5 days a week +; Drug: adjuvant TMZ 200mg; Drug: Talampanel; Drug: temozolomide(TMZ) 75mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00267592

IXR-207-21-189 / NABTT 0304

Details and patient eligibility

About

The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be 18 years of age
• Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
• Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
• Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
• Patients must have a Karnofsky performance of at least 60% or more.

Exclusion criteria

• Patients with serious concurrent infection or medical illness.
• Patients receiving concurrent chemotherapeutics or investigational agents.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

enzyme-inducing antiseizure drug

Experimental group

Description:

A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.

Treatment:

Drug: temozolomide(TMZ) 75mg

Drug: adjuvant TMZ 200mg

Radiation: Radiation Therapy (RT) 5 days a week +

Drug: Talampanel