Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Biological: Recombinant Interferon Alfa (INF alpha)
- Registration Number
- NCT00002965
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Benign Meningiomas Recombinant Interferon Alfa (INF alpha) INF alpha as a subcutaneous injection Monday to Friday for 8 weeks. Arm 2: Other Pathologies Recombinant Interferon Alfa (INF alpha) INF alpha as subcutaneous injection Monday to Friday for 8 weeks.
- Primary Outcome Measures
Name Time Method Number of Patients with Dose Limiting Toxicity (DLT) Each 8 weeks Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States