Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: Primary * Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on the pharmacokinetics of celecoxib in patients with newly diagnosed glioblastoma multiforme undergoing radiotherapy. * Determine the effects of steroids on the pharmacokinetics of celecoxib in these patients. Secondary * 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: * Phenytoin * Carbamazepine * Phenobarbital * Primidone * Oxcarbazepine * 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: * Gabapentin * Lamotrigine * Valproic acid * Levetiracetam * Tiagabine * Topiramate * Zonisamide * Felbamate * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
