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

December 21, 2023 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Benign Meningiomas
INF alpha as a subcutaneous injection Monday to Friday for 8 weeks.
Biological: Recombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.
Other Names:
  • Roferon
  • Interferon Alfa
  • Alpha 2 Interferon
  • IFN alpha-2A
  • IFN-Alpha 2
  • Interferon alfa 2a
  • Recombinant Interferon Alfa-2a
Experimental: Arm 2: Other Pathologies
INF alpha as subcutaneous injection Monday to Friday for 8 weeks.
Biological: Recombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.
Other Names:
  • Roferon
  • Interferon Alfa
  • Alpha 2 Interferon
  • IFN alpha-2A
  • IFN-Alpha 2
  • Interferon alfa 2a
  • Recombinant Interferon Alfa-2a

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Wai-Kwan A. Yung, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 10, 2003

First Posted (Estimated)

July 11, 2003

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM96-296
  • P30CA016672 (U.S. NIH Grant/Contract)
  • MDA-DM-96296 (Other Identifier: UT MD Anderson Cancer Center)
  • NCI-G97-1206
  • CDR0000065463 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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