Stage IV Renal Cell Cancer Clinical Trial
Official title:
A Phase II Trial of Celecoxib Plus Interferon Alpha in Metastatic Renal Cell Carcinoma Patients With 3+ COX-2 Tumor Immunostaining
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of
cancer cells and slow the growth of kidney cancer. Giving celecoxib together with
recombinant interferon alpha-2b may kill more tumor cells and be an effective treatment for
metastatic kidney cancer.
PURPOSE: This phase II trial is studying how well giving celecoxib together with recombinant
interferon alfa-2b works in treating patients with metastatic kidney cancer who have
undergone surgery.
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of interferon alpha plus celecoxib in metastatic
RCC patients with 3+ COX-2 tumor immunostaining.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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
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