Safety and Efficacy of Talampanel in Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title:

A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267592
• Other study ID #: IXR-207-21-189 / NABTT 0304
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2005
• Last updated: March 19, 2013
• Start date: December 2005
• Est. completion date: February 2011

Study information

• Verified date: March 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00082992

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2011
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Talampanel
Radiation Therapy (RT) 5 days a week + temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks. One month later, adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months. Talampanel was administered orally TID beginning the first day of RT + TMZ and continued until there was talampanel-related toxicity or tumor progression.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		24 months	Yes
Secondary	Talampanel-related toxicity		29 months	Yes