Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine
Status:
Terminated
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Brown University Children's Hospital of Pittsburg Mayo Clinic National Cancer Institute (NCI) Seattle Children's Hospital Texas Children's Hospital University of Pittsburgh