NCT00547131

Temozolomide in Treating Patients With Primary Brain Tumors or Metastatic Brain Tumors

A Pilot Feasibility Study of Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Temozolomide

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	temozolomide
OTHER	laboratory biomarker analysis
OTHER	liquid chromatography
OTHER	mass spectrometry
OTHER	pharmacological study
PROCEDURE	conventional surgery
RADIATION	stereotactic radiosurgery

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-05-01
• Completion: 2009-05-01
• First posted: 2007-10-22
• Last updated: 2018-04-17

Locations

2 sites across 1 country: United States