Interferon Alfa in Treating Patients With Advanced Kidney Cancer
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients with advanced kidney cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study of Subcutaneous Administration of Pegylated-Interferon Alpha-2A (RO 25-8310) in Previously Untreated Patients With Locally Advanced or Metastatic Renal Cell Carcinoma|
|Study Start Date:||May 1998|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of pegylated-interferon alfa-2a in patients with advanced or metastatic renal cell carcinoma. II. Evaluate the safety profile of the MTD in this patient population. III. Determine the objective response rate, time to response, duration of response, time to progression, and survival rate in this patient population.
OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive pegylated-interferon alfa-2a (PEG-IFN) subcutaneously once a week for 24 weeks. Dose escalation of PEG-IFN continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. After the MTD of PEG-IFN is determined, additional patients are treated at this dose level. These patients may continue treatment after the first 24 weeks for up to 1 year, in the absence of disease progression. Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 46-58 patients will be accrued for this study within 9 months.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Robert J. Motzer, MD||Memorial Sloan-Kettering Cancer Center|