Safety and Efficacy of Talampanel in Glioblastoma Multiforme

NCT00267592 | Completed Phase 2

• 1 other identifier: IXR-207-21-189 / NABTT 0304
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  24 months

Secondary Outcomes (1)

• Talampanel-related toxicity

  29 months

Study Arms (1)

enzyme-inducing antiseizure drug

EXPERIMENTAL

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.

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

Interventions

Talampanel DRUG

Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.

enzyme-inducing antiseizure drug

Radiation Therapy (RT) 5 days a week + RADIATION

enzyme-inducing antiseizure drug

temozolomide(TMZ) 75mg DRUG

temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks

enzyme-inducing antiseizure drug

adjuvant TMZ 200mg DRUG

adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.

enzyme-inducing antiseizure drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

talampanel; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 21, 2005
• Study Start: December 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: February 1, 2011
• Last Updated: May 19, 2016

Record last verified: 2016-04