A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide
- 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
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.
Primary Purpose: Treatment
Correlation of pharmacokinetics with incidence of dose-limiting toxicities
Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|