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Terminated Phase 1 Interventional

Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine

ClinicalTrials.gov ID: NCT00074607

Public ClinicalTrials.gov record NCT00074607. 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 7, 2026, 2:50 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

Intrathecal Gemcitabine Therapy for Neoplastic Meningitis: A Phase I and Pharmacokinetic Study

Brief summary

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

Subject's are being asked to take part in this study because he or she has a type of cancer that has spread to the meninges (tissues that cover the brain and spinal cord). There is no known effective treatment for this specific disease or the subject has received all of the treatments that are known to work for his or her specific disease without success. Currently, there is no other effective treatment for this type of cancer. The purposes of this study are: * to determine the highest dose of gemcitabine, an anti-cancer drug, that can safely be given directly into the spinal fluid of children and adults whose cancer no longer responds to standard treatment; * to find out what effects (good and bad) gemcitabine has when given directly into the cerebrospinal fluid (called intrathecal administration) in children and adults with neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord); * to determine if gemcitabine is beneficial to the patient; * to understand how gemcitabine is handled by the body after intrathecal administration.

Study identification

NCT ID
NCT00074607
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Baylor College of Medicine
Other
Enrollment
10 participants

Conditions and interventions

Interventions

Drug

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
Nov 30, 2001
Primary completion
Jun 30, 2005
Completion
Mar 31, 2007
Last update posted
Nov 11, 2012

2001 – 2007

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
National Cancer Institute Bethesda Maryland 20892
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15213
University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania 15213
Texas Children's Hospital Houston Texas 77030
Seattle Children's Hospital 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 NCT00074607, 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 Nov 11, 2012 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00074607 live on ClinicalTrials.gov.

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