Name of the Trial
Phase I Study of Intrathecal Gemcitabine in Patients with Neoplastic Meningitis Secondary to Leukemia, Lymphoma, or a Solid Tumor (NCI-03-C-0032). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-03-C-0032.

Principal Investigator
Dr. Lisa Bomgaars, Texas Children's Cancer Center

Why Is This Trial Important?
Neoplastic meningitis is a condition in which cancer cells spread into the membranes surrounding the brain and the spinal cord (the meninges). Often, the condition is associated with cancer that has spread from tumors elsewhere in the body. Neoplastic meningitis is difficult to treat because chemotherapy drugs injected intravenously often do not reach high enough concentrations in the meninges to be effective. Consequently, chemotherapy for neoplastic meningitis is often given intrathecally, injected into the fluid-filled space between the meninges.

This study seeks to determine whether the drug gemcitabine (Gemzar) may be effective in treating neoplastic meningitis caused by the spread of a primary leukemia, lymphoma, or solid tumor. Gemcitabine is active against many of the types of cancer that tend to spread to the meninges, and may prove effective in treating secondary neoplastic meningitis."The agents available to treat neoplastic meningitis are quite limited," said Dr. Bomgaars. "Gemcitabine is an agent that works differently from other treatments for this condition. If effective, it will be a welcomed new option for patients fighting neoplastic meningitis."

Who Can Join This Trial?
Researchers seek to enroll 25-30 patients aged 3 and over who have been diagnosed with neoplastic meningitis secondary to an underlying leukemia/lymphoma or a solid tumor (including primary central nervous system tumors or carcinomas of unknown primary site) for which there is no conventional therapy. See the full list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-03-C-0032.

Where Is This Trial Taking Place?
Study sites in the United States are enrolling patients in the trial. See the list of sites at http://cancer.gov/clinicaltrials/NCI-03-C-0032.

Who To Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/NCI-03-C-0032 or call the NCI's Clinical Studies Support Center (CSSC) at 1-888-NCI-1937. The call is toll free and completely confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.