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NCT00062881 · ClinicalTrials.gov registry record · Phase 1

Intrathecal Mafosfamide

A Phase 1 study of Malignant Meningeal Neoplasms, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target
10
Study locations

NCT00062881 is a Phase 1 study of Malignant Meningeal Neoplasms that has completed, run by Baylor College of Medicine. The registered enrollment target is 65 participants. The trial reports 10 study locations across 9 states.

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The verdict

NCT00062881, a Phase 1 study of Malignant Meningeal Neoplasms, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target
10
Study locations

Study Summary

This research study is an investigational treatment with the experimental drug Mafosfamide. This treatment is only for children with cancer that has spread to the meninges (tissues that cover the spinal column and brain) and has continued to grow despite treatment with standard therapy. Mafosfamide is a drug reported to have antitumor effects in animals and that has been given safely into the cerebrospinal fluid (the fluid within and surrounding the brain) in a small number of children and adults. Since there is limited experience in adults and children in giving mafosfamide in this way, the main purpose of this study is to determine the appropriate safe dose of mafosfamide when given intrathecally, that is directly into the cerebrospinal fluid. The purposes for this study are to (a) determine what dose of mafosfamide can be safely given into the cerebrospinal fluid through an Ommaya reservoir (surgically implanted catheters used to sample cerebrospinal fluid and to instill medication into the cerebrospinal fluid) and lumbar puncture (spinal tap) or lumbar reservoir; (b) look for side effects of drug treatment; (c) to study the pharmacology (how the human body handles the drug) when given directly into the spinal fluid; and (d) see if this drug is beneficial to the patient.

Interventions

  • DRUG Intrathecal Mafosfamide

Study Locations (10)

Texas

  • M.D. Anderson Cancer Center - Houston
  • Texas Children's Hospital - Houston

California

  • Children'sHospital Los Angeles - Los Angeles

District of Columbia

  • Children's Hospital National Medical Center - Washington D.C.

Florida

  • Mayo Clinic - Jacksonville

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Maryland

  • Pediatric Branch, National Cancer Institute - Bethesda

Minnesota

  • Mayo Clinic - Rochester

Vermont

  • Neurological Research Center - Bennington

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 1990-06
Est. Completion 2005-09
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT00062881

The ClinicalTrials.gov registry entry for NCT00062881 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Malignant Meningeal Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Intrathecal Mafosfamide is the first listed.

NCT00062881 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Texas, California, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00062881 about?

NCT00062881 is a clinical study titled "Intrathecal Mafosfamide". This research study is an investigational treatment with the experimental drug Mafosfamide. This treatment is only for children with cancer that has spread to the meninges (tissues that cover the spinal column and brain) and has continued to grow despite treatment with standard therapy. Mafosfamide...

What is the current status of trial NCT00062881?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 1990-06. Estimated completion is 2005-09.

What conditions does trial NCT00062881 study?

This clinical trial studies the following conditions: Malignant Meningeal Neoplasms.

What interventions are being tested in trial NCT00062881?

The interventions under investigation include: Intrathecal Mafosfamide (DRUG).

Who is sponsoring clinical trial NCT00062881?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00062881 being conducted?

This trial has 10 study locations across California, District of Columbia, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.