Conditions: Renal Cell Cancer Stage IV Renal Cell Cancer
Keywords: recurrent renal cell cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: celecoxib intervention 2: recombinant interferon alfa-2b intervention 3: polymerase chain reaction intervention 4: laboratory biomarker analysis intervention 5: reverse transcriptase-polymerase chain reaction intervention 6: immunologic technique intervention 7: immunohistochemistry staining method intervention 8: flow cytometry
Intervention descriptions: intervention 1: Given orally intervention 2: Given subcutaneously intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies

Protocol document: