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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: Completed Phase 1 study of Malignant Meningeal Neoplasms, sponsored by Baylor College of Medicine.
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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 1990-06 |
| Est. Completion | 2005-09 |
| Phase | Phase 1 |
What the finished NCT00062881 record still lists
NCT00062881 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 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 lists 10 locations in 9 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00062881'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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