RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.
OBJECTIVES: * Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy. * Determine the maximum tolerated dose of this drug in these patients. * Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks (induction therapy). Patients then receive intrathecal mafosfamide once weekly for 4 weeks (consolidation therapy), twice a month for 4 months, and then monthly thereafter (maintenance therapy) in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3000 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
3,000
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Texas Children's Cancer Center
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Neurological Research Center, Inc.
Bennington, Vermont, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States