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- 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.
Eligible patients will receive gemcitabine directly into the cerebrospinal fluid (fluid that circulates around the brain and spinal cord) by one of the following methods. It will take about 10 minutes to give the gemcitabine.
- Ommaya Reservoir: An Ommaya reservoir is a surgically implanted catheter that is used to inject medication or to withdraw cerebrospinal fluid from the fluid chambers in the head.
All patients will be hospitalized overnight following their first dose of gemcitabine. If the first dose is well tolerated, further doses of gemcitabine will be administered in the outpatient clinic with close observation for a minimum of 2 hours after administration.
Weeks 1-6 Cohort 1 (first three patients): Gemcitabine will be given once a week for 6 weeks. Patients may continue therapy if the disease has not worsened.
Weeks 1-6 Cohort 2: Gemcitabine will be given twice a week for 6 weeks. Patients may continue therapy if the disease has not worsened.
Weeks 7-12: Gemcitabine will be given twice a week for 6 weeks.
Weeks 13-29 (approximately): Gemcitabine will be given twice monthly for 4 months.
Weeks 30-52 (approximately): Gemcitabine will be given monthly for the duration of the study.
For safety reasons, the first patients treated in the study will receive a low dose of gemcitabine. If that dose does not cause severe side effects, the next group will receive a higher dose of gemcitabine than given to the earlier group, or may receive a lower dose if side effects occur. In addition, the first three patients treated on this study will receive the gemcitabine once weekly. If this is tolerated, subsequent patients will receive the medication twice weekly.
Following the first dose of gemcitabine we would like to draw special blood and spinal fluid samples to help us learn how much of the drug is in the blood and spinal fluid. These studies are called pharmacokinetics. A total of 10 blood samples will be collected. These samples will be drawn with the first dose of gemcitabine. The spinal fluid samples may be collected either via Ommaya reservoir or lumbar reservoir. Participation in the pharmacokinetics portion of this study is optional.
In addition to intrathecal gemcitabine, patients may receive other chemotherapy, not given directly into the fluid surrounding the brain and spine, as recommended by their doctor for the treatment or prevention of cancer outside the lining of the brain and spinal cord.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Gemcitabine, Lumbar puncture (LP, Spinal Tap)
National Cancer Institute - Pediatric Oncology Branch
Baylor College of Medicine
Published on BioPortfolio: 2014-08-27T03:54:44-0400
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