Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors; Cancer-Related Problem/Condition
Intervention: temozolomide (Drug); comparative genomic hybridization (Procedure); laboratory biomarker analysis (Procedure); pharmacological study (Procedure); polymorphism analysis (Procedure); radiation therapy (Procedure)
Sponsored by: Sidney Kimmel Comprehensive Cancer Center
Official(s) and/or principal investigator(s):
Stuart A. Grossman, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center
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.
Official title: A Pharmacokinetic and Pharmacogenomic Study of Patients With High-Grade Gliomas Receiving Daily Radiation Therapy and Temozolomide
Study design: Treatment
Primary outcome: Correlation of pharmacokinetics with
incidence of dose-limiting toxicities
Maximum concentration of temozolomide
Polymorphisms in the MGMT repair gene
- 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.
Minimum age: 18 Years.
Maximum age: N/A.
- Histologically confirmed high-grade glioma (WHO grade III or IV)
- Must be scheduled to receive standard first-line therapy (cranial radiotherapy and
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1. 7 mg/dL
- Bilirubin ≤ 1. 5 mg/dL
- Transaminases ≤ 4 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except curatively treated carcinoma in
situ or basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
- No prior hormonal therapy for brain tumor
- No prior biological agents (including immunotoxins, immunoconjugates, antisense
agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating
lymphocytes, lymphokine-activated killer cells, or gene therapy)
- No prior immunotherapy
- No prior chemotherapy
- No prior radiotherapy, including cranial radiotherapy
- Concurrent glucocorticoid therapy allowed
- No concurrent carbamazepine
- No other concurrent experimental therapy
- No other concurrent cytotoxic therapy
Locations and Contacts
City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States; Recruiting
Clinical Trials Office - City of Hope Comprehensive Cancer Cen, Phone: 800-826-4673, Email: email@example.com
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States; Recruiting
Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce, Phone: 410-955-8804, Email: firstname.lastname@example.org
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 2006
Last updated: October 18, 2008