S9624 Ifosfamide in Treating Patients With Meningeal Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ifosfamide in treating patients with meningeal tumors that have recurred or that cannot be removed surgically.
Adult Malignant Meningioma
Adult Brain Malignant Hemangiopericytoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||S9624: Phase II Study of Ifosfamide in Patients With Aggressive Meningeal Tumors|
|Study Start Date:||July 1998|
|Study Completion Date:||January 2004|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
- Estimate failure free survival, overall survival, and response in patients with residual or recurrent/progressive aggressive meningeal tumors (malignant meningioma, hemangiopericytoma, and primary nervous system sarcoma) treated with ifosfamide.
- Evaluate toxicities of ifosfamide in this patient population.
OUTLINE: All patients receive ifosfamide IV continuously over 72 hours on days 1-3 of each 21 day treatment course. Patients are evaluated for response/progression after every 2 courses. Patients with stable disease receive up to 8 courses of therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study.
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|Study Chair:||Leslie McAllister, MD||Neurological Clinic|
|Study Chair:||Lynn G. Feun, MD||University of Miami Sylvester Comprehensive Cancer Center|