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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00547131 |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Collecting fluid samples through a catheter may help doctors find out how well temozolomide spreads throughout the brain.
PURPOSE: This clinical trial is studying temozolomide in treating patients with primary brain tumors or metastatic brain tumors.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Drug: temozolomide Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study Procedure: conventional surgery Radiation: stereotactic radiosurgery |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Feasibility Study of Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Temozolomide |
Estimated Enrollment: | 12 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are assessed for viable tumor during a debulking craniotomy or stereotactic biopsy. If viable tumor is confirmed, patients undergo placement of an intracerebral microdialysis (MD) catheter. The catheter, which is perfused continuously over 24 hours with artificial cerebrospinal fluid, is placed directly into the residual brain tumor or peritumoral brain tissue for neuropharmacokinetic studies of temozolomide. At least 25 hours but no more than 72 hours after placement of the catheter, patients receive a single dose of oral temozolomide. At the same time, intracerebral MD is initiated and serial samples of dialysate (i.e., brain extracellular fluid [ECF]) are collected periodically over 24 hours for analysis of intracerebral concentrations of temozolomide by liquid chromatography/tandem mass spectrometry. Serial blood samples for measuring plasma levels of temozolomide are also drawn and plasma temozolomide levels are compared with those in the brain ECF. Additional ECF samples are obtained to assess biochemical markers of brain tumor metabolism (i.e., glucose, lactate, pyruvate, glutamate, or glycerol) at least one hour before and 24 hours after administration of temozolomide.
After completion of study therapy, patients are followed for up to 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 |
Principal Investigator: | Jana Portnow, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000570280, CHNMC-05117 |
Study First Received: | October 19, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00547131 History of Changes |
Health Authority: | United States: Federal Government |
adult tumors metastatic to brain recurrent adult brain tumor |
Brain Neoplasms Central Nervous System Diseases Antineoplastic Agents, Alkylating Central Nervous System Neoplasms Brain Diseases |
Alkylating Agents Temozolomide Recurrence Nervous System Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Temozolomide Pharmacologic Actions |
Brain Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms |