A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Stuart A. Grossman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
NABTT-2100 CDR0000328117
NCT ID:
NCT00068770
Start Date:
October 2003
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| 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 |
