A Phase 1 interventional study of temozolomide and laboratory biomarker analysis in Brain and Central Nervous System Tumors and Metastatic Cancer, sponsored by City of Hope Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment
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:
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.
538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.
This study's planned enrollment of 12 is below the median of 35 across 379 interventional studies indexed under Nervous System Neoplasms.
Browse Nervous System Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Incidence rate of clinically symptomatic intratumoral hemorrhage
Incidence rate of CNS infection
Incidence rate of catheter malfunction
Systemic and intracerebral pharmacokinetic profile of temozolomide using a microdialysis catheter
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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City of Hope Medical Center