Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas
NCT ID: NCT00002965
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
1997-01-31
2003-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: Benign Meningiomas
INF alpha as a subcutaneous injection Monday to Friday for 8 weeks.
Recombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.
Arm 2: Other Pathologies
INF alpha as subcutaneous injection Monday to Friday for 8 weeks.
Recombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.
Interventions
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Recombinant Interferon Alfa (INF alpha)
Subcutaneous injection Monday through Friday for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Wai-Kwan A. Yung, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-DM-96296
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G97-1206
Identifier Type: -
Identifier Source: secondary_id
CDR0000065463
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM96-296
Identifier Type: -
Identifier Source: org_study_id