Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Registration Number
- NCT00002847
- Lead Sponsor
- Blumenthal Cancer Center at Carolinas Medical Center
- Brief Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.
- Detailed Description
OBJECTIVES:
* Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa.
* Assess the toxicity of this regimen.
OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden.
All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited.
Patients are followed for survival.
PROJECTED ACCRUAL: 14 patients will be entered.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center🇺🇸Charlotte, North Carolina, United States