Overview

Phase I Study of Intrathecal Mafosfamide

Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine efficacy of intrathecal mafosfamide, a preactivated derivative of cyclophosphamide against meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). The maximally tolerated dose for intrathecal mafosfamide will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal mafosfamide will also be studied. Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed by twice monthly administration for four months and then monthly IT administration. A minimum of 9 patients will be studied in each disease category (leukemias, lymphomas, and other malignancies refractory to conventional therapy).
Phase:
Phase 1
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Mafosfamide