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

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma

Intervention: aldesleukin (Proleukin) (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
David F McDermott, MD, Study Chair, Affiliation: Beth Israel Deaconess Medical Center
Kim Margolin, MD, Principal Investigator, Affiliation: City of Hope National Medical Center
Walter Urba, MD, Principal Investigator, Affiliation: Chiles Cancer Center
Marc Ernstoff, MD, Principal Investigator, Affiliation: Dartmouth-Hitchcock Medical Center
Theodore Logan, MD, Principal Investigator, Affiliation: Indiana University
Joseph Clark, MD, Principal Investigator, Affiliation: Loyola University
Janice Dutcher, MD, Principal Investigator, Affiliation: Our Lady of Mercy Cancer Center
Michael Wong, MD, Principal Investigator, Affiliation: Roswell Park Cancer Institute
Allen Pantuck, MD, Principal Investigator, Affiliation: University of California, Los Angeles
Leslie Oleksowicz, MD, Principal Investigator, Affiliation: University of Cincinnati
Leonard Appleman, MD, Principal Investigator, Affiliation: University of Pittsburgh
Geoffrey Weiss, MD, Principal Investigator, Affiliation: University of Virginia
Jeffrey Sosman, MD, Principal Investigator, Affiliation: Vanderbilt University
Ulka Vaishampayan, MD, Principal Investigator, Affiliation: Wayne State University


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.

Clinical Details

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 design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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 outcome: 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


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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.

Locations and Contacts

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Additional Information

Related publications:

McDermott DF. Update on the application of interleukin-2 in the treatment of renal cell carcinoma. Clin Cancer Res. 2007 Jan 15;13(2 Pt 2):716s-720s. Review.

Atkins M, Regan M, McDermott D, Mier J, Stanbridge E, Youmans A, Febbo P, Upton M, Lechpammer M, Signoretti S. Carbonic anhydrase IX expression predicts outcome of interleukin 2 therapy for renal cancer. Clin Cancer Res. 2005 May 15;11(10):3714-21.

Starting date: November 2006
Last updated: February 3, 2014

Page last updated: August 23, 2015

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