Clinical trial · Interventional

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

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

NCT00554515CI-TRIAL-00080258SELECTcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastatic Renal Cell Carcinoma	Renal Cell Carcinoma	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
HD IL2	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
HD IL2
description
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.
interventionNames
1. Drug: HD IL2

Primary outcomes (1)

measure
Objective Response in ISM Good Risk Group
timeFrame
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).
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (3)

BACKGROUNDMcDermott 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
BACKGROUNDAtkins 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
RESULTMcDermott 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

Registry

Dates and enrollment

Start: Nov 1, 2006
Primary completion: Oct 31, 2013
Completion: Oct 31, 2013
First posted: Nov 7, 2007
Last update posted: Aug 28, 2024
Results first posted: May 19, 2017
Enrollment: 123 (actual)
Lead sponsor: Beth Israel Deaconess Medical Center OTHER
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; Dana-Farber Cancer Institute
Keywords: Kidney, Renal Cell, Metastatic, interleukin-2, select

Data updated 22 days agoSource updated Aug 28, 2024source: clinicaltrials

Locations

Locations by country (1)

Country	Sites