NCT01158534

Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery

A Phase II Trial of Celecoxib Plus Interferon Alpha in Metastatic Renal Cell Carcinoma Patients With 3+ COX-2 Tumor Immunostaining

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	Given orally
BIOLOGICAL	recombinant interferon alfa-2b	Given subcutaneously
OTHER	polymerase chain reaction	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	reverse transcriptase-polymerase chain reaction	Correlative studies
OTHER	immunologic technique	Correlative studies
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	flow cytometry	Correlative studies

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2010-07-08
• Last updated: 2012-08-07
• Results posted: 2012-07-12

Locations

1 site across 1 country: United States