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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00002965
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
 Biological: Recombinant Interferon Alfa (INF alpha)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Dose Limiting Toxicity (DLT) [ Time Frame: Each 8 weeks ] [ Designated as safety issue: No ]
    Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).


Enrollment: 16
Study Start Date: January 1997
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002965

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Wai-Kwan A. Yung, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
UT MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00002965     History of Changes
Other Study ID Numbers: DM96-296, P30CA016672, MDA-DM-96296, NCI-G97-1206, CDR0000065463
Study First Received: November 1, 1999
Last Updated: July 27, 2012
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
recurrent adult brain tumor

Additional relevant MeSH terms:
Meningioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Interferon-alpha
Interferon Alfa-2a
 Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013