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NCT00001251 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of Intrathecal Mafosfamide

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT00001251: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00001251 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00001251, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study 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).

Interventions

  • DRUG Mafosfamide

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 1989-11
Est. Completion 2003-11
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001251 record still lists

NCT00001251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Mafosfamide is the first listed.

NCT00001251 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001251 about?

NCT00001251 is a clinical study titled "Phase I Study of Intrathecal Mafosfamide". 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 establ...

What is the current status of trial NCT00001251?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 1989-11. Estimated completion is 2003-11.

What interventions are being tested in trial NCT00001251?

The interventions under investigation include: Mafosfamide (DRUG).

Who is sponsoring clinical trial NCT00001251?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001251's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001251, the US trial registry maintained by the National Library of Medicine. NCT00001251 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.