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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00547131
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 20, 2011
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Brain and Central Nervous System Tumors Metastatic Cancer Drug: temozolomide Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study Procedure: conventional surgery Radiation: stereotactic radiosurgery

Detailed Description:


  • 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Study of Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Temozolomide
Study Start Date : January 2006
Primary Completion Date : May 2008
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Incidence rate of clinically symptomatic intratumoral hemorrhage
  2. Incidence rate of CNS infection
  3. Incidence rate of catheter malfunction

Secondary Outcome Measures :
  1. Systemic and intracerebral pharmacokinetic profile of temozolomide using a microdialysis catheter

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of a primary or metastatic brain tumor for which temozolomide would be an appropriate chemotherapy treatment postoperatively
  • Disease requires a debulking craniotomy or a stereotactic biopsy to diagnose or differentiate between tumor progression and treatment-induced effects after radiotherapy with or without chemotherapy


  • Karnofsky performance status 60-100%
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 2.0 mg/dL
  • AST ≤ 4 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 time ULN
  • Mini Mental Status Exam score ≥ 15
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No allergy to temozolomide
  • No serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study treatment


  • See Disease Characteristics
  • Recovered from prior therapy
  • No concurrent chemotherapy or radiotherapy during the period of time that the microdialysis catheter is placed intracerebrally and until it is removed
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547131

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
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Jana Portnow, MD City of Hope Comprehensive Cancer Center
More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00547131     History of Changes
Other Study ID Numbers: 05117
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000570280 ( Registry Identifier: NCI PDQ )
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011

Keywords provided by City of Hope Medical Center:
tumors metastatic to brain
recurrent adult brain tumor

Additional relevant MeSH terms:
Neoplasm Metastasis
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents