Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy
Recruitment status was Active, not recruiting
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.
Brain and Central Nervous System Tumors
Genetic: comparative genomic hybridization
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: pharmacological study
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide|
- Correlation of pharmacokinetics with incidence of dose-limiting toxicities [ Designated as safety issue: Yes ]
- Maximum concentration of temozolomide [ Designated as safety issue: No ]
- Polymorphisms in the MGMT repair gene [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471653
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center|