A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
- Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on the
pharmacokinetics of celecoxib in patients with newly diagnosed glioblastoma multiforme
- Determine the effects of steroids on the pharmacokinetics of celecoxib in these
- Determine the safety of celecoxib in these patients.
- Determine the duration of survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients are assigned to 1 of 2 groups based on anticonvulsant therapy.
- Group A: Patients treated with any of the following anticonvulsant drugs that induce
hepatic metabolic enzymes:
- Group B: Patients treated with any of the following anticonvulsant drugs that cause
modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug:
- Valproic acid
- Induction therapy: Patients in both groups receive oral celecoxib twice* daily on weeks
1-11 and undergo radiotherapy 5 days a week on weeks 2-7.
- Maintenance therapy: Patients receive oral celecoxib twice daily. Courses repeat every
4 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive only 1 dose on the first day of celecoxib administration.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 44 patients (22 per group) will be accrued for this study
within approximately 8 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Stuart A. Grossman, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|