Temozolomide in Treating Patients With Primary Brain Tumors or Metastatic Brain Tumors - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00547131

Purpose

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
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

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Feasibility Study of Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Temozolomide

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence rate of clinically symptomatic intratumoral hemorrhage [ Designated as safety issue: No ]
Incidence rate of CNS infection [ Designated as safety issue: No ]
Incidence rate of catheter malfunction [ Designated as safety issue: No ]

Secondary Outcome Measures:

Systemic and intracerebral pharmacokinetic profile of temozolomide using a microdialysis catheter [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	January 2006
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547131

Locations

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

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jana Portnow, MD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

adult tumors metastatic to brain
recurrent adult brain tumor

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Antineoplastic Agents, Alkylating
Central Nervous System Neoplasms
Brain Diseases

Alkylating Agents
Temozolomide
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009