Back to resultsInterleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
Primary Purpose
Kidney Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring renal cell cancer, renal cell carcinoma, interleukin-2
Eligibility Criteria
Inclusion Criteria An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL. Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing. No history or evidence of cardiac disease on ECG No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment. No prior history of invasive malignancy in the past 5 years Human immunodeficiency virus (HIV) negative Female patients must not be pregnant or planning to become pregnant Exclusion criteria • Age younger than 16
Sites / Locations
- Cancer Center and Beckman Research Institute, City of Hope
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA
- Summit Medical Center
- Loyola University Medical Center
- Indiana University Cancer Center
- Beth Israel Deaconess Medical Center
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Norris Cotton Cancer Center
- Our Lady of Mercy Medical Center
- Carolinas Medical Center
- Earle A. Chiles Research Institute at Providence Portland Medical Center
- Vanderbilt-Ingram Cancer Center
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interleukin-2 (IL-2)
Observation
Arm Description
Patients randomized to this arm will receive one course of IL-2 [600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)].
Patients randomized to this arm will receive their normal medical care
Outcomes
Primary Outcome Measures
Disease free survival
Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up.
Secondary Outcome Measures
Overall survival
Overall survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death. Living patients will be censored at the date of last follow-up.
Full Information
NCT ID
NCT00003126
First Posted
November 1, 1999
Last Updated
January 2, 2017
Sponsor
Loyola University
Collaborators
Chiron Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00003126
Brief Title
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
Official Title
A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola University
Collaborators
Chiron Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
Detailed Description
The primary objective of this prospective, randomized, controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.
Patients are stratified according to their disease classification and randomized to one course of IL-2 [600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28 doses)] or observation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
renal cell cancer, renal cell carcinoma, interleukin-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interleukin-2 (IL-2)
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive one course of IL-2 [600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)].
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Patients randomized to this arm will receive their normal medical care
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Other Intervention Name(s)
IL-2, Aldesleukin
Intervention Description
High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
Primary Outcome Measure Information:
Title
Disease free survival
Description
Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up.
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death. Living patients will be censored at the date of last follow-up.
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.
Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing.
No history or evidence of cardiac disease on ECG
No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment.
No prior history of invasive malignancy in the past 5 years
Human immunodeficiency virus (HIV) negative
Female patients must not be pregnant or planning to become pregnant
Exclusion criteria
• Age younger than 16
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph I. Clark, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Summit Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Our Lady of Mercy Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Earle A. Chiles Research Institute at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data
Citations:
PubMed Identifier
12568441
Citation
Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5.
Results Reference
background
PubMed Identifier
5125665
Citation
Skinner DG, Colvin RB, Vermillion CD, Pfister RC, Leadbetter WF. Diagnosis and management of renal cell carcinoma. A clinical and pathologic study of 309 cases. Cancer. 1971 Nov;28(5):1165-77. doi: 10.1002/1097-0142(1971)28:53.0.co;2-g. No abstract available.
Results Reference
background
PubMed Identifier
28012766
Citation
Robson CJ, Churchill BM, Anderson W. The Results of Radical Nephrectomy for Renal Cell Carcinoma. J Urol. 2017 Feb;197(2S):S111-S113. doi: 10.1016/j.juro.2016.10.095. Epub 2016 Dec 21. No abstract available.
Results Reference
background
PubMed Identifier
10561319
Citation
Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. doi: 10.1200/JCO.1999.17.8.2530.
Results Reference
background
PubMed Identifier
12663707
Citation
Messing EM, Manola J, Wilding G, Propert K, Fleischmann J, Crawford ED, Pontes JE, Hahn R, Trump D; Eastern Cooperative Oncology Group/Intergroup trial. Phase III study of interferon alfa-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern Cooperative Oncology Group/Intergroup trial. J Clin Oncol. 2003 Apr 1;21(7):1214-22. doi: 10.1200/JCO.2003.02.005.
Results Reference
background
PubMed Identifier
7081138
Citation
Poster DS, Bruno S, Penta JS, Pinna K, Vilk P, Macdonald JS. Current status of chemotherapy, hormonal therapy, and immunotherapy in the treatment of renal cell carcinoma. Am J Clin Oncol. 1982 Feb;5(1):53-60.
Results Reference
background
PubMed Identifier
4712834
Citation
Finney R. The value of radiotherapy in the treatment of hypernephroma--a clinical trial. Br J Urol. 1973 Jun;45(3):258-69. doi: 10.1111/j.1464-410x.1973.tb12152.x. No abstract available.
Results Reference
background
PubMed Identifier
3553111
Citation
Kjaer M, Frederiksen PL, Engelholm SA. Postoperative radiotherapy in stage II and III renal adenocarcinoma. A randomized trial by the Copenhagen Renal Cancer Study Group. Int J Radiat Oncol Biol Phys. 1987 May;13(5):665-72. doi: 10.1016/0360-3016(87)90283-5.
Results Reference
background
PubMed Identifier
9179659
Citation
Naito S, Kumazawa J, Omoto T, Iguchi A, Sagiyama K, Osada Y, Hiratsuka Y. Postoperative UFT adjuvant and the risk factors for recurrence in renal cell carcinoma: a long-term follow-up study. Kyushu University Urological Oncology Group. Int J Urol. 1997 Jan;4(1):8-12. doi: 10.1111/j.1442-2042.1997.tb00130.x.
Results Reference
background
PubMed Identifier
11208835
Citation
Pizzocaro G, Piva L, Colavita M, Ferri S, Artusi R, Boracchi P, Parmiani G, Marubini E. Interferon adjuvant to radical nephrectomy in Robson stages II and III renal cell carcinoma: a multicentric randomized study. J Clin Oncol. 2001 Jan 15;19(2):425-31. doi: 10.1200/JCO.2001.19.2.425.
Results Reference
background
PubMed Identifier
8120958
Citation
Rosenberg SA, Yang JC, Topalian SL, Schwartzentruber DJ, Weber JS, Parkinson DR, Seipp CA, Einhorn JH, White DE. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2. JAMA. 1994 Mar 23-30;271(12):907-13.
Results Reference
background
PubMed Identifier
7884429
Citation
Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995 Mar;13(3):688-96. doi: 10.1200/JCO.1995.13.3.688.
Results Reference
background
PubMed Identifier
10685660
Citation
Fisher RI, Rosenberg SA, Fyfe G. Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S55-7.
Results Reference
background
PubMed Identifier
2647914
Citation
Margolin KA, Rayner AA, Hawkins MJ, Atkins MB, Dutcher JP, Fisher RI, Weiss GR, Doroshow JH, Jaffe HS, Roper M, et al. Interleukin-2 and lymphokine-activated killer cell therapy of solid tumors: analysis of toxicity and management guidelines. J Clin Oncol. 1989 Apr;7(4):486-98. doi: 10.1200/JCO.1989.7.4.486.
Results Reference
background
PubMed Identifier
3495213
Citation
Belldegrun A, Webb DE, Austin HA 3rd, Steinberg SM, White DE, Linehan WM, Rosenberg SA. Effects of interleukin-2 on renal function in patients receiving immunotherapy for advanced cancer. Ann Intern Med. 1987 Jun;106(6):817-22. doi: 10.7326/0003-4819-106-6-817.
Results Reference
background
PubMed Identifier
8478661
Citation
Atkins MB, Sparano J, Fisher RI, Weiss GR, Margolin KA, Fink KI, Rubinstein L, Louie A, Mier JW, Gucalp R, et al. Randomized phase II trial of high-dose interleukin-2 either alone or in combination with interferon alfa-2b in advanced renal cell carcinoma. J Clin Oncol. 1993 Apr;11(4):661-70. doi: 10.1200/JCO.1993.11.4.661.
Results Reference
background
PubMed Identifier
1732429
Citation
Weiss GR, Margolin KA, Aronson FR, Sznol M, Atkins MB, Dutcher JP, Gaynor ER, Boldt DH, Doroshow JH, Bar MH, et al. A randomized phase II trial of continuous infusion interleukin-2 or bolus injection interleukin-2 plus lymphokine-activated killer cells for advanced renal cell carcinoma. J Clin Oncol. 1992 Feb;10(2):275-81. doi: 10.1200/JCO.1992.10.2.275.
Results Reference
background
PubMed Identifier
11917944
Citation
Atkins MB, Dutcher J, Weiss G, Margolin K, Clark J, Sosman J, Logan T, Aronson F, Mier J; Cytokine Working Group. Kidney cancer: the Cytokine Working Group experience (1986-2001): part I. IL-2-based clinical trials. Med Oncol. 2001;18(3):197-207. doi: 10.1385/MO:18:3:197.
Results Reference
background
PubMed Identifier
9307205
Citation
Guinan P, Sobin LH, Algaba F, Badellino F, Kameyama S, MacLennan G, Novick A. TNM staging of renal cell carcinoma: Workgroup No. 3. Union International Contre le Cancer (UICC) and the American Joint Committee on Cancer (AJCC). Cancer. 1997 Sep 1;80(5):992-3. doi: 10.1002/(sici)1097-0142(19970901)80:53.0.co;2-q. No abstract available.
Results Reference
background
PubMed Identifier
11917945
Citation
Dutcher J, Atkins MB, Margolin K, Weiss G, Clark J, Sosman J, Logan T, Aronson F, Mier J; Cytokine Working Group. Kidney cancer: the Cytokine Working Group experience (1986-2001): part II. Management of IL-2 toxicity and studies with other cytokines. Med Oncol. 2001;18(3):209-19. doi: 10.1385/MO:18:3:209.
Results Reference
background
PubMed Identifier
16113605
Citation
Upton MP, Parker RA, Youmans A, McDermott DF, Atkins MB. Histologic predictors of renal cell carcinoma response to interleukin-2-based therapy. J Immunother. 2005 Sep-Oct;28(5):488-95. doi: 10.1097/01.cji.0000170357.14962.9b.
Results Reference
background
PubMed Identifier
9562581
Citation
Negrier S, Escudier B, Lasset C, Douillard JY, Savary J, Chevreau C, Ravaud A, Mercatello A, Peny J, Mousseau M, Philip T, Tursz T. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Engl J Med. 1998 Apr 30;338(18):1272-8. doi: 10.1056/NEJM199804303381805.
Results Reference
background
PubMed Identifier
15625368
Citation
McDermott DF, Regan MM, Clark JI, Flaherty LE, Weiss GR, Logan TF, Kirkwood JM, Gordon MS, Sosman JA, Ernstoff MS, Tretter CP, Urba WJ, Smith JW, Margolin KA, Mier JW, Gollob JA, Dutcher JP, Atkins MB. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005 Jan 1;23(1):133-41. doi: 10.1200/JCO.2005.03.206. Erratum In: J Clin Oncol. 2005 Apr 20;23(12):2877.
Results Reference
background
PubMed Identifier
10999727
Citation
Dutcher JP, Logan T, Gordon M, Sosman J, Weiss G, Margolin K, Plasse T, Mier J, Lotze M, Clark J, Atkins M. Phase II trial of interleukin 2, interferon alpha, and 5-fluorouracil in metastatic renal cell cancer: a cytokine working group study. Clin Cancer Res. 2000 Sep;6(9):3442-50.
Results Reference
background
PubMed Identifier
12810695
Citation
Clark JI, Atkins MB, Urba WJ, Creech S, Figlin RA, Dutcher JP, Flaherty L, Sosman JA, Logan TF, White R, Weiss GR, Redman BG, Tretter CP, McDermott D, Smith JW, Gordon MS, Margolin KA. Adjuvant high-dose bolus interleukin-2 for patients with high-risk renal cell carcinoma: a cytokine working group randomized trial. J Clin Oncol. 2003 Aug 15;21(16):3133-40. doi: 10.1200/JCO.2003.02.014. Epub 2003 Jun 16.
Results Reference
result
Learn more about this trial
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
We'll reach out to this number within 24 hrs