CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
Mafosfamidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001251
NCT00001251Phase 1Completed

Phase I Study of Intrathecal Mafosfamide

National Cancer Institute (NCI)·interventional·Posted Nov 4, 1999·Updated Aug 19, 2013

In Brief

A Phase 1 clinical trial evaluating Mafosfamide for Leukemia and 2 related conditions. Completed, across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartNov 1, 1989
Study CompletionNov 1, 2003
TodayJul 2, 2026
Posted 26.7 years ago

Interventions

Mafosfamidedrug