Brain and Central Nervous System Tumors
Conditions
Keywords
recurrent adult brain tumor
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.
Interventions
BIOLOGICALRecombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed