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Keep this study
Lead
M.D. Anderson Cancer Center
With
National Cancer Institute (NCI)
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.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas