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