Phase I Study of Intrathecal Mafosfamide
- 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.
Primary Purpose: Treatment
Susan M. Blaney, MD
Texas Children's Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|Texas Children's Cancer Center||Houston, Texas 77030-2399|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Neurological Research Center, Inc.||Bennington, Vermont 05201|