NCT00031928

Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors

Phase I Study of Intrathecal Mafosfamide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	mafosfamide

Timeline

• Start date: 2002-01-01
• First posted: 2003-01-27
• Last updated: 2015-04-30

Locations

9 sites across 1 country: United States