A Phase II Trial of Celecoxib Plus Interferon Alpha in Metastatic Renal Cell Carcinoma Patients With 3+ COX-2 Tumor Immunostaining
I. To estimate the objective response rate of interferon alpha plus celecoxib in metastatic
RCC patients with 3+ COX-2 tumor immunostaining.
I. To compare cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor
immunostaining to patients with < 1+ tumor immunostaining.
II. To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune
parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining.
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b
subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate Assessed by RECIST Criteria.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.
at week 4 of cycle 2 and every other cycle thereafter
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|