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

NCT00554515 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: DFHCC 06-149
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kidney; Renal Cell; Metastatic; interleukin-2; select

Outcome Measures

Primary Outcomes (1)

• Objective Response in ISM Good Risk Group

  The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on World Health Organization (WHO) criteria. \[Miller et al. Cancer 1981\] Per WHO, evaluation of tumor measurements of measurable lesions centers on the percent change from baseline in the sum of the perpendicular diameters. Complete Response (CR) is disappearance of all clinical and laboratory evidence of disease; Partial Response (PR) is a \>/= 50% decrease. PR status also requires no simultaneous increase in the size of any metastatic lesion, absence of one or more new metastatic lesions and/or unequivocal progression of existing non-target lesions. CR and PR status needs confirmation within 4 weeks. Response status was determined by investigator assessment of radiographs.

  Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).

Secondary Outcomes (13)

• Objective Response Rate in ISM Poor Risk Group

  Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).

• Objective Response Rate (Independent Assessment)

  Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).

• Overall Survival

  Participants were followed for survival up to 7 years.

• 3-Year Progression-Free Survival Rate

  Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Long-term follow-up occurred every 3 m for 2 yrs, semi-annually for yr 3 and annually for yrs 4 and 5. Relevant for this endpoint was disease status at 3 y.

• Objective Response Rate by MSKCC Risk Group

  Disease was evaluated radiologically at baseline and during weeks 8 and 12 of each course. Participants received up to 3 courses of 12 weeks duration each. Median (range) days on treatment: 20 (1-262).

Study Arms (1)

HD IL2

EXPERIMENTAL

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.

Drug: HD IL2

Interventions

HD IL2 DRUG

Also known as: Proleukin, Aldesleukin

HD IL2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• City of Hope National Medical Center: collaborator
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Indiana University: collaborator
• Loyola University: collaborator
• Our Lady of Mercy Medical Center: collaborator
• Roswell Park Cancer Institute: collaborator
• University of California, Los Angeles: collaborator
• University of Cincinnati: collaborator
• University of Pittsburgh: collaborator
• University of Virginia: collaborator
• Vanderbilt University: collaborator
• Wayne State University: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• 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.

  PMID: 17255299 BACKGROUND

• 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.

  PMID: 15897568 BACKGROUND

• 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.

  PMID: 25424850 RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David F. McDermott, MD
• Organization: Beth Israel Deaconess Medical Center

dmcdermo@bidmc.harvard.edu

Study Officials

• David F McDermott, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: November 1, 2006
• Primary Completion: October 31, 2013
• Study Completion: October 31, 2013
• Last Updated: August 28, 2024
• Results First Posted: May 19, 2017

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)