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