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.
- 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.
- Histologically proven tumors:
- Unresectable meningioma
- Atypical meningioma
- Malignant meningioma
- Angioblastic meningioma
- Recurrent or progressive, unresectable tumor after failing radiation therapy or
refused radiation therapy following 2 surgeries
- 16 and over
- Karnofsky at least 60%
- At least 3 months
- AGC at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- SGPT less than 2.0 times normal
- Alkaline phosphatase less than 2.0 times normal
- Bilirubin less than 1.5 mg/dL
- BUN less than 1.5 times normal OR
- Creatinine less than 1.5 times normal
- 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:
- No concurrent biologic therapy
- Prior chemotherapy allowed and recovered from all myelotoxicity secondary to the
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
- Prior radiotherapy allowed
- Not specified