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Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas

Brain and Central Nervous System Tumors Clinical Trial

Official title:
Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002965
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date January 1997
Completion date March 2003
View Details
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