Recombinant Interferon-Alpha in Recurrent Unresectable and Malignant Meningiomas Treatment
This phase 2 study aims to evaluate the safety and effectiveness of Recombinant Interferon-Alpha as a single agent treatment for recurrent unresectable and malignant meningiomas, specifically by measuring the number of patients with Dose Limiting Toxicity (DLT).
Weekly INF Alpha Injections for 8 Weeks
+ Weekly INF Alpha Injections for 8 Weeks
Brain Diseases+5
+ Central Nervous System Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: January 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.16 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas - MD Anderson Cancer Center
Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps