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Completed Phase 1 Interventional

Intrathecal Mafosfamide

ClinicalTrials.gov ID: NCT00062881

Public ClinicalTrials.gov record NCT00062881. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 1:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Study of Intrathecal Mafosfamide

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00062881
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Baylor College of Medicine
Other
Enrollment
65 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 1990
Primary completion
Not listed
Completion
Aug 31, 2005
Last update posted
Mar 3, 2020

1990 – 2005

United States locations

U.S. sites
10
U.S. states
9
U.S. cities
9
Facility City State ZIP Site status
Children'sHospital Los Angeles Los Angeles California 90027
Children's Hospital National Medical Center Washington D.C. District of Columbia 20010
Mayo Clinic Jacksonville Florida 32224
Children's Healthcare of Atlanta Atlanta Georgia 30342
Pediatric Branch, National Cancer Institute Bethesda Maryland 20892
Mayo Clinic Rochester Minnesota 55905
M.D. Anderson Cancer Center Houston Texas 77030
Texas Children's Hospital Houston Texas 77030
Neurological Research Center Bennington Vermont 05210
Children's Hospital and Medical Center Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00062881, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2020 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00062881 live on ClinicalTrials.gov.

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