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


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Metastatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Incidence rate of clinically symptomatic intratumoral hemorrhage

Safety Issue:

No

Principal Investigator

Jana Portnow, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

05117

NCT ID:

NCT00547131

Start Date:

January 2006

Completion Date:

May 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Metastatic Cancer
  • tumors metastatic to brain
  • recurrent adult brain tumor
  • Brain Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location
City of Hope Comprehensive Cancer Center Duarte, California  91010
City of Hope Medical Group Pasadena, California  91105