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Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002965
  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
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 20
Study Start Date: January 1997
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

Ages Eligible for Study:   16 Years and older
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 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

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000065463, MDA-DM-96296, NCI-G97-1206
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002965     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor

Study placed in the following topic categories:
Interferon-alpha
Anti-Infective Agents
Meningeal Neoplasms
Interferon Type I, Recombinant
Immunologic Factors
Interferons
Central Nervous System Neoplasms
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Brain Neoplasms
Meningioma
Interferon Alfa-2a
Nervous System Neoplasms

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

ClinicalTrials.gov processed this record on September 02, 2009