Spots Global Cancer Trial Database for Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
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Trial Identification
Brief Title: Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
Official Title: Phase I Study of Intrathecal Mafosfamide
Study ID: NCT00031928
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
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
Contact Details
Name: Susan M. Blaney, MD
Affiliation: Texas Children's Cancer Center
Role: STUDY_CHAIR
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