The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma (SELECT)
High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug Administration (FDA) for the treatment of metastatic kidney cancer and is a standard treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer that can produce a remission of disease that lasts after treatment is completed. However, most patients who receive IL-2 do not benefit and all patients experience potentially dangerous side effects.
Recent research has suggested that certain patients may respond better to IL-2 than others. The Cytokine Working Group is currently conducting a clinical trial that aims to identify and confirm this research and narrow the application of IL-2 to those patients most likely to benefit. This trial is being conducted at 14 treatment centers in the Untied States that specialize in giving IL-2. All patients who are eligible for enrollment in the study will receive the FDA approved regimen of high-dose IL-2. To identify markers that may predict response to IL-2, patients are asked to provide a piece of their original tumor for research. They are not required to have a separate tumor biopsy. Blood samples (2-3 tablespoons) for research will also be drawn prior to treatment and tumor measurements will be obtained before and after treatment.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The High-Dose Aldesleukin (IL-2) "Select" Trial: A Trial Designed to Prospectively Validate Predictive Models of Response to High Dose IL-2 Treatment in Patients With Metastatic Renal Cell Carcinoma|
- To determine, in a prospective fashion, if the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "good" pathologic predictive features is significantly higher than a historical, unselected patient population [ Time Frame: months ] [ Designated as safety issue: No ]
- To determine the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "poor" pathologic predictive features and to compare this response rate to the response rate of patients with "good" pathologic predictive features [ Time Frame: months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Drug: aldesleukin (Proleukin)
Eligible patients will receive treatment with IL-2 alone following the FDA approved schedule. A treatment course consists of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 8-12 weeks of rest. A cycle is defined as 5 days of treatment.
Patients will receive IL-2, 600,000 International Units/kg/dose (Chiron) intravenously (IV) every 8 (q8) hours for five days (maximum of 14 doses), beginning on day 1 and again on day 15.
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||David F McDermott, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Kim Margolin, MD||City of Hope National Medical Center|
|Principal Investigator:||Walter Urba, MD||Chiles Cancer Center|
|Principal Investigator:||Marc Ernstoff, MD||Dartmouth-Hitchcock Medical Center|
|Principal Investigator:||Theodore Logan, MD||Indiana University|
|Principal Investigator:||Joseph Clark, MD||Loyola University|
|Principal Investigator:||Janice Dutcher, MD||Our Lady of Mercy Cancer Center|
|Principal Investigator:||Michael Wong, MD||Roswell Park Cancer Institute|
|Principal Investigator:||Allen Pantuck, MD||University of California, Los Angeles|
|Principal Investigator:||Leslie Oleksowicz, MD||University of Cincinnati|
|Principal Investigator:||Leonard Appleman, MD||University of Pittsburgh|
|Principal Investigator:||Geoffrey Weiss, MD||University of Virginia|
|Principal Investigator:||Jeffrey Sosman, MD||Vanderbilt University|
|Principal Investigator:||Ulka Vaishampayan, MD||Wayne State University|