Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
NCT ID: NCT00003126
Last Updated: 2017-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
69 participants
INTERVENTIONAL
1997-06-30
2002-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interleukin-2 (IL-2)
Patients randomized to this arm will receive one course of IL-2 \[600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)\].
Interleukin-2
High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
Observation
Patients randomized to this arm will receive their normal medical care
No interventions assigned to this group
Interventions
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Interleukin-2
High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
ALL
No
Sponsors
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Chiron Corporation
INDUSTRY
Loyola University
OTHER
Responsible Party
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Principal Investigators
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Joseph I. Clark, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Summit Medical Center
Oakland, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Our Lady of Mercy Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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852006
Identifier Type: -
Identifier Source: org_study_id
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