The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma
NCT ID: NCT00554515
Last Updated: 2024-08-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2006-11-30
2013-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HD IL2
Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
HD IL2
Interventions
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HD IL2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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City of Hope National Medical Center
OTHER
Providence Cancer Center, Earle A. Chiles Research Institute
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Indiana University
OTHER
Loyola University
OTHER
Our Lady of Mercy Medical Center
OTHER
Roswell Park Cancer Institute
OTHER
University of California, Los Angeles
OTHER
University of Cincinnati
OTHER
University of Pittsburgh
OTHER
University of Virginia
OTHER
Vanderbilt University
OTHER
Wayne State University
OTHER
Dana-Farber Cancer Institute
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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David McDermott
Principal Investigator
Principal Investigators
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David F McDermott, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Kim Margolin, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope National Medical Center
Walter Urba, MD
Role: PRINCIPAL_INVESTIGATOR
Chiles Cancer Center
Marc Ernstoff, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Theodore Logan, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Joseph Clark, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Janice Dutcher, MD
Role: PRINCIPAL_INVESTIGATOR
Our Lady of Mercy Cancer Center
Michael Wong, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Allen Pantuck, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Leslie Oleksowicz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Leonard Appleman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Geoffrey Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Jeffrey Sosman, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Ulka Vaishampayan, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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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. doi: 10.1158/1078-0432.CCR-06-1872.
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. doi: 10.1158/1078-0432.CCR-04-2019.
McDermott DF, Cheng SC, Signoretti S, Margolin KA, Clark JI, Sosman JA, Dutcher JP, Logan TF, Curti BD, Ernstoff MS, Appleman L, Wong MK, Khushalani NI, Oleksowicz L, Vaishampayan UN, Mier JW, Panka DJ, Bhatt RS, Bailey AS, Leibovich BC, Kwon ED, Kabbinavar FF, Belldegrun AS, Figlin RA, Pantuck AJ, Regan MM, Atkins MB. The high-dose aldesleukin "select" trial: a trial to prospectively validate predictive models of response to treatment in patients with metastatic renal cell carcinoma. Clin Cancer Res. 2015 Feb 1;21(3):561-8. doi: 10.1158/1078-0432.CCR-14-1520. Epub 2014 Nov 25.
Other Identifiers
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DFHCC 06-149
Identifier Type: -
Identifier Source: org_study_id
NCT00536757
Identifier Type: -
Identifier Source: nct_alias