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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002965
• Other study ID #: DM96-296
• Secondary ID: P30CA016672MDA-D
• Status: Completed
• Phase: Phase 2
• Start date: January 1997
• Est. completion date: March 2003

Study information

• Verified date: December 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Meningioma
• Nervous System Neoplasms

Intervention

Biological:
• Recombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Dose Limiting Toxicity (DLT)	Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).	Each 8 weeks

External Links

•   UT MD Anderson Cancer Center Website