The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma

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.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

DRUG

HD IL2

Sponsors & Collaborators

• City of Hope National Medical Center

  collaborator OTHER

• Providence Cancer Center, Earle A. Chiles Research Institute

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Loyola University

  collaborator OTHER

• Our Lady of Mercy Medical Center

  collaborator OTHER

• Roswell Park Cancer Institute

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• David F McDermott, MD · Beth Israel Deaconess Medical Center

• Kim Margolin, MD · City of Hope National Medical Center

• Walter Urba, MD · Chiles Cancer Center

• Marc Ernstoff, MD · Dartmouth-Hitchcock Medical Center

• Theodore Logan, MD · Indiana University

• Joseph Clark, MD · Loyola University

• Janice Dutcher, MD · Our Lady of Mercy Cancer Center

• Michael Wong, MD · Roswell Park Cancer Institute

• Allen Pantuck, MD · University of California, Los Angeles

• Leslie Oleksowicz, MD · University of Cincinnati

• Leonard Appleman, MD · University of Pittsburgh

• Geoffrey Weiss, MD · University of Virginia

• Jeffrey Sosman, MD · Vanderbilt University

• Ulka Vaishampayan, MD · Wayne State University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2013-10-31

Completion

2013-10-31

FDA Drug

Yes

Countries

• United States

Study Locations