Metastatic Cancer Clinical Trial
Official title:
A Pilot Feasibility Study of Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Temozolomide
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.
OBJECTIVES:
- Determine the feasibility of microdialysis for assessing the intracerebral distribution
of temozolomide in patients with primary or metastatic brain tumors.
- Determine the interstitial pharmacokinetics of temozolomide using an intracerebral
microdialysis catheter in these patients.
- Determine the feasibility of assessing brain tumor metabolism using a microdialysis
catheter to measure intracerebral levels of glucose, lactate, pyruvate, glutamate, and
glycerol in these patients.
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.
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