Spots Global Cancer Trial Database for The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
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Trial Identification
Brief Title: The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
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
Study ID: NCT00554515
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * 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. Secondary * To determine, in a prospective fashion, 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. * To determine if components of other predictive and prognostic models (e.g MSKCI or UCLA criteria) can help to further define the optimal population to receive high-dose IL2 for metastatic renal cell carcinoma. * To identify features of the baseline immune function (arginine, arginase, T cell zeta chain) of patients with metastatic renal cell carcinoma that are associated with response to high-dose IL-2. * To identify new proteins or patterns of gene expression that might be associated with high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy to those who will benefit the most.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Contact Details
Name: David F McDermott, MD
Affiliation: Beth Israel Deaconess Medical Center
Role: STUDY_CHAIR
Name: Kim Margolin, MD
Affiliation: City of Hope National Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Walter Urba, MD
Affiliation: Chiles Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Marc Ernstoff, MD
Affiliation: Dartmouth-Hitchcock Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Theodore Logan, MD
Affiliation: Indiana University
Role: PRINCIPAL_INVESTIGATOR
Name: Joseph Clark, MD
Affiliation: Loyola University
Role: PRINCIPAL_INVESTIGATOR
Name: Janice Dutcher, MD
Affiliation: Our Lady of Mercy Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Wong, MD
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Allen Pantuck, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
Name: Leslie Oleksowicz, MD
Affiliation: University of Cincinnati
Role: PRINCIPAL_INVESTIGATOR
Name: Leonard Appleman, MD
Affiliation: University of Pittsburgh
Role: PRINCIPAL_INVESTIGATOR
Name: Geoffrey Weiss, MD
Affiliation: University of Virginia
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Sosman, MD
Affiliation: Vanderbilt University
Role: PRINCIPAL_INVESTIGATOR
Name: Ulka Vaishampayan, MD
Affiliation: Wayne State University
Role: PRINCIPAL_INVESTIGATOR
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