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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Biological: Recombinant Interferon Alfa (INF alpha)


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven tumors: Unresectable meningioma Atypical meningioma Malignant meningioma Angioblastic meningioma Hemangiopericytoma Recurrent or progressive, unresectable tumor after failing radiation therapy or refused radiation therapy following 2 surgeries PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky at least 60% Life expectancy: At least 3 months Hematopoietic: AGC at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: SGPT less than 2.0 times normal Alkaline phosphatase less than 2.0 times normal Bilirubin less than 1.5 mg/dL Renal: BUN less than 1.5 times normal OR Creatinine less than 1.5 times normal Other: No active infection No diseases that obscure toxicity or dangerously alter drug metabolism No serious intercurrent medical illness Not pregnant Fertile patients must use adequate contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: Prior chemotherapy allowed and recovered from all myelotoxicity secondary to the therapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: Prior radiotherapy allowed Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Benign Meningiomas<br>INF alpha as a subcutaneous injection Monday to Friday for 8 weeks. | Biological: Recombinant Interferon Alfa (INF alpha)<br>* Subcutaneous injection Monday through Friday for 8 weeks.<br>* Other names: Recombinant Interferon Alfa-2a;|
| Experimental: Arm 2: Other Pathologies<br>INF alpha as subcutaneous injection Monday to Friday for 8 weeks. | Biological: Recombinant Interferon Alfa (INF alpha)<br>* Subcutaneous injection Monday through Friday for 8 weeks.<br>* Other names: Recombinant Interferon Alfa-2a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult brain tumor