Safety and Efficacy of Talampanel in Glioblastoma Multiforme

Study Overview
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Brief Summary
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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.

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

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: Talampanel
* Radiation: Radiation Therapy (RT) 5 days a week +
* Drug: temozolomide(TMZ) 75mg
* Drug: adjuvant TMZ 200mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enzyme-inducing antiseizure drug<br>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<br>* Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.<br>Radiation: Radiation Therapy (RT) 5 days a week +<br> <br> Drug: temozolomide(TMZ) 75mg<br>* temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks<br>Drug: adjuvant TMZ 200mg<br>* adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Talampanel-related toxicity |  | 29 months |