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Sponsors and Collaborators: |
Baylor College of Medicine Texas Children's Hospital |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00074607 |
Gemcitabine is an investigational drug for treatment of neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord). The purposes of this study are:
Condition | Intervention | Phase |
---|---|---|
Meningitis Neoplasms |
Drug: Gemcitabine Procedure: Lumbar puncture (LP, Spinal Tap) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Intrathecal Gemcitabine Therapy for Neoplastic Meningitis: A Phase I and Pharmacokinetic Study |
Estimated Enrollment: | 30 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | August 2006 |
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.
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.
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
National Cancer Institute - Pediatric Oncology Branch | |
Bethesda, Maryland, United States, 20892 | |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15213 | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Seattle Children's Hospital | |
Seattle, Washington, United States, 98105 |
Study ID Numbers: | H10564, I.T. Gemcitabine |
Study First Received: | December 16, 2003 |
Last Updated: | August 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00074607 |
Health Authority: | United States: Food and Drug Administration |
Neoplastic meningitis |
Central Nervous System Infections Central Nervous System Diseases Gemcitabine Meningitis |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses |