Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Intrathecal Mafosfamide|
|Study Start Date:||January 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031928
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Texas|
|Texas Children's Cancer Center|
|Houston, Texas, United States, 77030-2399|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Vermont|
|Neurological Research Center, Inc.|
|Bennington, Vermont, United States, 05201|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Study Chair:||Susan M. Blaney, MD||Texas Children's Cancer Center|