Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Recruitment status was: Active, not recruiting
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.
|Kidney Cancer||Biological: aldesleukin Biological: recombinant interferon alfa Procedure: conventional surgery||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA|
|Study Start Date:||September 1995|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002847
|United States, North Carolina|
|Blumenthal Cancer Center at Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28232-2861|
|Study Chair:||Richard L. White, MD||Blumenthal Cancer Center at Carolinas Medical Center|