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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002965 |
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 |
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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 |
Estimated Enrollment: | 20 |
Study Start Date: | January 1997 |
OBJECTIVES:
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven tumors:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Wai-Kwan A. Yung, MD | M.D. Anderson Cancer Center |
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 |
recurrent adult brain tumor |
Interferon-alpha Meningeal Neoplasms Interferon Type I, Recombinant Immunologic Factors Interferons Central Nervous System Neoplasms Antiviral Agents |
Angiogenesis Inhibitors Recurrence Brain Neoplasms Meningioma Interferon Alfa-2a Nervous System Neoplasms |
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 |