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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
City of Hope National Medical Center
Providence Cancer Center, Earle A. Chiles Research Institute
Dartmouth-Hitchcock Medical Center
Indiana University
Loyola University
Our Lady of Mercy Medical Center
Roswell Park Cancer Institute
University of California, Los Angeles
University of Cincinnati
University of Pittsburgh
University of Virginia
Vanderbilt University
Wayne State University
Information provided by (Responsible Party):
David F. McDermott, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00554515
First received: November 6, 2007
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: aldesleukin (Proleukin)
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
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)
Arms Assigned Interventions
Experimental: A
High-dose IL-2
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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed renal cell carcinoma that is metastatic or unresectable.
  • If patients have measurable disease restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
  • Patients must provide access to tissue blocks containing adequate tumor for interpretation and analysis.
  • Patients must have measurable disease.
  • Patients must have good performance status (ECOG 0 or 1; Karnofsky PS 100-80%).
  • Patients must have adequate organ function.
  • Patients must have no contraindication of vasopressor agents.
  • Patients must be ≥ 18 years of age.

Exclusion Criteria:

  • Patients who have received systemic therapy for metastatic disease.
  • Patients with organ allografts.
  • Patients who require or are likely to require systemic corticosteroid therapy for intercurrent illness.
  • Patients with any significant medical disease other than the malignancy (e.g. COPD, patients with ascites or pleural effusions), which in the opinion of the investigator would significantly increase the risk of immunotherapy.
  • Patients with a history of another malignancy within the past 5 years other than surgically cured non-melanoma skin cancer, carcinoma-in-situ or Stage I carcinoma of the cervix.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554515

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
City of Hope National Medical Center
Providence Cancer Center, Earle A. Chiles Research Institute
Dartmouth-Hitchcock Medical Center
Indiana University
Loyola University
Our Lady of Mercy Medical Center
Roswell Park Cancer Institute
University of California, Los Angeles
University of Cincinnati
University of Pittsburgh
University of Virginia
Vanderbilt University
Wayne State University
Investigators
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
  More Information

Publications:
Responsible Party: David F. McDermott, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00554515     History of Changes
Obsolete Identifiers: NCT00536757
Other Study ID Numbers: DFHCC 06-149
Study First Received: November 6, 2007
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Kidney
Renal Cell
Metastatic
interleukin-2
select

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Aldesleukin
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014