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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Biological: Recombinant Interferon Alfa (INF alpha)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00002965

P30CA016672 (U.S. NIH Grant/Contract)

NCI-G97-1206

DM96-296

CDR0000065463 (Registry Identifier)

MDA-DM-96296 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Arm 1: Benign Meningiomas

Experimental group

Description:

INF alpha as a subcutaneous injection Monday to Friday for 8 weeks.

Treatment:

Biological: Recombinant Interferon Alfa (INF alpha)

Arm 2: Other Pathologies

Experimental group

Description:

INF alpha as subcutaneous injection Monday to Friday for 8 weeks.

Treatment:

Biological: Recombinant Interferon Alfa (INF alpha)