Glioblastoma Multiforme
Conditions
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.
Interventions
DRUGTalampanel
Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.
RADIATIONRadiation Therapy (RT) 5 days a week +
DRUGtemozolomide(TMZ) 75mg
temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks
DRUGadjuvant TMZ 200mg
adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Talampanel-related toxicity | 29 months |
Outcome results
None listed