NCT00471653

Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy

A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors
• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	temozolomide
GENETIC	comparative genomic hybridization
GENETIC	polymorphism analysis
OTHER	laboratory biomarker analysis
OTHER	pharmacological study
RADIATION	radiation therapy

Timeline

• Start date: 2006-11-11
• Primary completion: 2008-11-12
• Completion: 2009-08-18
• First posted: 2007-05-10
• Last updated: 2018-07-09

Locations

2 sites across 1 country: United States