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.

Condition	Treatment or Intervention	Phase
recurrent adult brain tumor	Procedure: biological response modifier therapy  Procedure: interferon therapy  Procedure: cytokine therapy  Drug: interferon alfa	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas. II. Determine the nature and extent of central nervous system (CNS) toxicities associated with the use of alpha interferon in current doses and schedules.

PROTOCOL 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.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--Patient Characteristics--

Age: 16 and over

Performance status: Karnofsky at least 60%

Life expectancy: At least 3 months

Hematopoietic:

• AGC at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• SGPT less than 2.0 times normal
• Alkaline phophatase 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

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Wai-Kwan Alfred Yung,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000065463; MDA-DM-96296; NCI-G97-1206
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002965
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08