Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide
RATIONALE: Studying samples of blood in the laboratory from patients receiving temozolomide
may help doctors learn how temozolomide works in the body. It may also help doctors learn
more about how a patient's genes may affect the risk of developing thrombocytopenia.
PURPOSE: This clinical trial is studying the pharmacokinetics in patients with newly
diagnosed high-grade glioma receiving temozolomide and radiation therapy.
OBJECTIVES:
- Compare the pharmacokinetic (PK) profiles of temozolomide (TMZ) in patients who develop
severe thrombocytopenia vs PK profiles in patients who do not develop severe
thrombocytopenia while receiving standard first-line therapy for management of newly
diagnosed high-grade gliomas.
- Determine if patients who develop thrombocytopenia have any single nucleotide
polymorphisms in the O6-methylguanine-DNA methyltransferase gene.
OUTLINE: This is a pilot, prospective, multicenter study.
Patients receive oral temozolomide once daily on days 1-42. Patients also undergo cranial
radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable
toxicity.
Blood samples are collected periodically for pharmacokinetic and pharmacogenomic analysis,
genotype analysis, plasma temozolomide levels, and MGMT repair gene polymorphism analysis.
After completion of study treatment, patients are followed for 1 month.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
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