Phase I trial of BAY 50-4798, an interleukin-2-specific agonist in advanced melanoma and renal cancer

Clinical Cancer Research

Volumn 13, Issue 11, 2007, Pages 3312-3319

  Margolin, Kim ^a   Atkins, Michael B ^b   Dutcher, Janice P ^c   Ernstoff, Marc S ^d   Smith II, John W ^e   Clark, Joseph I ^f   Baar, Joseph ^g,h   Sosman, Jeffrey ⁱ   Weber, Jeffrey ^j   Lathia, Chetan ^k   Brunetti, Janice ^k   Cihon, Frank ^k   Schwartz, Brian ^k  

^a CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c Our Lady of Mercy Cancer Center   (United States)

^d DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^e EARLE A CHILES RESEARCH INSTITUTE   (United States)

^f LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^g Department of Pathology   (United States)

^h UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

ⁱ VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^j UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^k BAYER CORPORATION   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BAY 50 4798; INTERLEUKIN 2; RECOMBINANT INTERLEUKIN 2; UNCLASSIFIED DRUG;

ADULT; AGED; ANTIGEN SPECIFICITY; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG RESPONSE; DRUG SAFETY; FEMALE; HALF LIFE TIME; HEART ATRIUM FIBRILLATION; HUMAN; HYPONATREMIA; IMMUNOTHERAPY; KIDNEY CANCER; LYMPHOCYTE; MALE; MELANOMA; METASTASIS; NATURAL KILLER CELL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INTERLEUKIN-2; KIDNEY NEOPLASMS; LYMPHOCYTE SUBSETS; MALE; MELANOMA; MIDDLE AGED; RECOMBINANT PROTEINS; SKIN NEOPLASMS;

EID: 34250689881     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-06-1341     Document Type: Article

References (24)

1. Smith KA. Interleukin-2: inception, impact, and implications. Science 1988;240:1169-76.
2. Parkinson DR, Abrams JS, Wiernik PH, et al. Interleukin-2 therapy in patients with metastatic malignant melanoma: a phase II study. J Clin Oncol 1990;8:1650-6.
3. Rosenberg SA, Yang JC, Topalian SL, et al. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2. JAMA 1994;271:907-13.
4. McCabe MS, Stablein D, Hawkins MJ. The Modified Group C experience: phase III randomized trials of IL-2 vs IL-2/LAK in advanced renal cell carcinoma and advanced melanoma. Proc Am Soc Clin Oncol 1991;10:213.
5. Rosenberg SA, Lotze MT, Muul LM, et al. Observations on the systemic administration of autologous lymphokine-activated killer cells and recombinant interleukin-2 to patients with metastatic cancer. N Engl J Med 1985;313:1485-92.
6. McDermott DF, Regan MM, Clark JI, et al. 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;23:133-41.
7. Phan GQ, Attia P, Steinberg SM, White DE, Rosenberg SA. Factors associated with response to high-dose interleukin-2 in patients with metastatic melanoma. J Clin Oncol 2001;19:3477-82.
8. Shanafelt AB, Lin Y, Shanafelt MC, et al. A T-cell-selective interleukin 2 mutein exhibits potent antitumor activity and is well tolerated in vivo. Nat Biotechnol 2000;18:1197-202.
9. Siegel JP, Puri RK. Interleukin-2 toxicity. J Clin Oncol 1991;9:694-704.
10. Voss SD, Sondel PM, Robb RJ. Characterization of the interleukin 2 receptors (IL-2R) expressed on human natural killer cells activated in vivo by IL-2: association of the p64 IL-2Rγ chain with the IL-2Rβ chain in functional intermediate-affinity IL-2R. J Exp Med 1992;176:531-41.
11. Theze J, Alzari PM, Bertoglio J. Interleukin 2 and its receptors: recent advances and new immunological functions. Immunol Today 1996;17:481-6.
12. Harada Y, Yahara I. Pathogenesis of toxicity with human-derived interleukin-2 in experimental animals. Int Rev Exp Pathol 1993;34 Pt A:37-55.
13. Anderson TD, Hayes TJ, Powers GD, et al. Comparative toxicity and pathology associated with administration of recombinant IL-2 to animals. Int Rev Exp Pathol 1993;34 Pt A:57-77.
14. Anderson TD, Hayes TJ, Gately MK, et al. Toxicity of human recombinant interleukin-2 in the mouse is mediated by interleukin-activated lymphocytes. Separation of efficacy and toxicity by selective lymphocyte subset depletion. Lab Invest 1988;59:598-612.
15. Anderson TD, Hayes TJ. Toxicity of human recombinant interleukin-2 in rats. Pathologic changes are characterized by marked lymphocytic and eosinophilic proliferation and multisystem involvement. Lab Invest 1989;60:331-46.
16. Matthews L, Chapman S, Ramchandani MS, et al. BAY 50-4798, a novel, high-affinity receptor-specific recombinant interleukin-2 analog, induces dose-dependent increases in CD25 expression and proliferation among unstimulated, human peripheral blood mononuclear cells in vitro. Clin Immunol 2004;113:248-55.
17. Margolin KA, Rayner AA, Hawkins MJ, et al. Interleukin-2 and lymphokine-activated killer cell therapy of solid tumors: analysis of toxicity and management guidelines. JClin Oncol 1989;7:486-98.
18. Ponce P, Cruz J, Travassos J, et al. Renal toxicity mediated by continuous infusion of recombinant interleukin-2. Nephron 1993;64:114-8.
19. Schwartzentruber DJ. Guidelines for the safe administration of high-dose interleukin-2. J Immunother 2001;24:287-93.
20. Pawelec G. Tumour escape from the immune response: the last hurdle for successful immunotherapy of cancer? Cancer Immunol Immunother 1999;48:343-5.
21. Mapara MY, Sykes M. Tolerance and cancer: mechanisms of tumor evasion and strategies for breaking tolerance. JClin Oncol 2004;22:1136-51.
22. Phillips J, Gemlo B, Myers W, et al. In vivo and in vitro activation of natural killer cells in advanced cancer patients undergoing combined recombinant interleukin-2 and LAK cell therapy. J Clin Oncol 1987;5:1933-41.
23. Atkins MB, Mier JW, Parkinson DR, et al. Hypothyroidism after treatment with interleukin-2 and lymphokine-activated killer cells. N Engl J Med 1988;318:1557-63.
24. Sanderson K, Scotland R, Lee P, et al. Autoimmunity in a phase I trial of a fully human anti-cytotoxic T-lymphocyte antigen-4 monoclonal antibody with multiple melanoma peptides and Montanide ISA 51 for patients with resected stages III and IV melanoma. JClin Oncol 2005;23:741-50.