Clinical Trial: Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Study of Intrathecal Mafosfamide
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 Summary:
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.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: March 8, 2002
Date Started: January 2002
Date Completion:
Last Updated: April 29, 2015
Last Verified: November 2003
