Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme Supratentorial Grade IV astrocytoma PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal Renal Creatinine no greater than 1.7 mg/dL Creatinine clearance at least 60 mL/min No prior renal toxicity with nonsteroidal anti-inflammatory drugs Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Mini mental score at least 15 No history of peptic disease No serious concurrent infection No other medical illness that would preclude study participation No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer No allergy to sulfonamides Able to tolerate cyclo-oxygenase-2 (COX-2) inhibitors PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy or biologic agents for the malignancy, including any of the following: Immunotoxins Immunoconjugates Antisense agents Peptide receptor antagonists Interferons Interleukins Tumor-infiltrating lymphocytes Lymphokine-activated killer cells Gene therapy No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy No prior chemotherapy for the malignancy Endocrine therapy No prior hormonal therapy for the malignancy Prior glucocorticoid therapy allowed Concurrent corticosteroids allowed provided there has been no dose increase within the past 5 days Radiotherapy No prior radiotherapy for the malignancy Surgery Recovered from prior surgery Other At least 1 week since prior fluconazole More than 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes (Group A) No other prior therapy for the malignancy No concurrent enrollment in another therapeutic clinical trial No concurrent fluconazole
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
- Winship Cancer Institute of Emory University
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts General Hospital Cancer Center
- Comprehensive Cancer Center at Wake Forest University
- Cleveland Clinic Taussig Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
p450 ( +EIASD)
nonp450 (-EIASD)
on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine) celecoxib and radiation therapy will be adminstered with this arm
not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate. celecoxib and radiation therapy will be adminstered with this arm