Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas
- Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in
the treatment of recurrent unresectable meningiomas and malignant meningiomas.
- Determine the nature and extent of central nervous system (CNS) toxicities associated
with the use of alpha interferon in current doses and schedules.
OUTLINE: This is a two arm, randomized study. The first arm includes all histologically
benign meningiomas. The second arm includes all other pathologies.
All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8
weeks. Treatment continues without interruption as long as there is no tumor recurrence or
progression and toxicity is acceptable.
Treatment continues without dose adjustment for the first 8 weeks as long as there are no
toxic effects of grade III or greater. Dosage for subsequent courses is one dose level below
the dose that produced toxicity of grade III or greater.
PROJECTED ACCRUAL: 20 patients will be entered per year into each arm.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Dose Limiting Toxicity (DLT)
Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).
Each 8 weeks
Wai-Kwan A. Yung, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|