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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

24 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

IXR-207-21-189 / NABTT 0304

NCT ID:

NCT00267592

Start Date:

December 2005

Completion Date:

February 2011

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma

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