Denileukin diftitox: A novel immunotoxin

Expert Opinion on Biological Therapy

Volumn 9, Issue 11, 2009, Pages 1445-1451

  Manoukian, George ^b   Hagemeister, Fred ^a,b  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

Author keywords

Chemotherapy; Denileukin diftitox; IL 2; Immunotherapy; Lymphoma; Ontak

Indexed keywords

ALEMTUZUMAB; ALPHA INTERFERON; BEXAROTENE; CARMUSTINE; CHLORMETHINE; CORTICOSTEROID DERIVATIVE; CYCLOPHOSPHAMIDE; DENILEUKIN DIFTITOX; DEXAMETHASONE; DOXORUBICIN; FLUDARABINE; INTERLEUKIN 2; INTERLEUKIN 2 RECEPTOR; METHOTREXATE; VINCRISTINE;

ABNORMAL SUBSTRATE CONCENTRATION IN BLOOD; ARTHRALGIA; ASYMPTOMATIC TRANSIENT TRANSAMINASEMIA; B CELL LYMPHOMA; CANCER RADIOTHERAPY; CHEST TIGHTNESS; CHILL; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; CONFUSION; CUTANEOUS T CELL LYMPHOMA; DEMENTIA; DRUG EFFECT; DRUG ERUPTION; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG TOLERABILITY; DYSPNEA; EDEMA; FATIGUE; FOOD AND DRUG ADMINISTRATION; GRAFT VERSUS HOST REACTION; HEADACHE; HUMAN; HYPOALBUMINEMIA; HYPOTENSION; IMMUNOMODULATION; INFECTION; MULTIPLE CYCLE TREATMENT; MYALGIA; MYELOFIBROSIS; NAUSEA; NEUTROPENIA; NONHODGKIN LYMPHOMA; NONHUMAN; PHOTOCHEMOTHERAPY; PHOTOTHERAPY; PROTEIN FUNCTION; PROTEIN STRUCTURE; PSORIASIS; REVIEW; RHEUMATOID ARTHRITIS; SCLERODERMA; SYSTEMIC LUPUS ERYTHEMATOSUS; T CELL LEUKEMIA; T CELL LYMPHOMA; THROMBOCYTOPENIA; VASCULAR DISEASE; VASCULITIS; VOMITING;

ANTINEOPLASTIC AGENTS; DIPHTHERIA TOXIN; HUMANS; INTERLEUKIN-2; LYMPHOMA, T-CELL; RECOMBINANT FUSION PROTEINS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

HUMAN T-LYMPHOTROPIC VIRUS 1;

EID: 70350645181     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712590903348135     Document Type: Review

References (37)

1. Foss FM. DAB389IL-2 (Ontak): a novel fusion toxin therapy for lymphoma. Clin Lymphoma 2000;2:110-116
2. Smith KA. The structure of IL-2 bound to the three chains of the IL2 receptor and how signaling occurs. Med Immunol 2006;5:3
3. Minami Y, KoNo T, Miyazaki T, Taniguchi T. The IL-2 receptor complex: its structure, function, and target genes. Annu Rev Immunol 1993;11:245-268 (Pubitemid 23115008)
4. Eklund JW, Kuzel TM. Denileukin diftitox: a concise clinical review. Expert Rev Anticancer Ther 2005;5:33-38
5. Caliquiri MA, Zmuidzinas A, Manley TJ, et al. Functional consequences of interleukin 2 receptor expression on resting human lymphocytes. Identification of a novel natural killer cell subset with high affinity receptor. J Exp Med 1990;171(5):1509-1526 (Pubitemid 20167547)
6. Dang NH, Pro B, Hagemeister FB, et al. Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma. Br J Haematol 2007;136:439-447 • This trial tested denileukin diftitox in peripheral T-cell lymphomas, excluding myeosis fungoides, CD25 expression was not needed to obtain a response in therapy of this disease. (Pubitemid 46046302)
7. Research discovers CTCL incidence rising in US. Birmingham, Michigan, Cutaneous T-Cell Lymphoma Foundation, Fall 2007 forum. Available from: www.clfoundation.org/publications/forum-fall-07.pdf. [Last accessed 21 September 2009]
8. Cutaneous T-cell lymphoma - treatment options. New York, USA: Lymphoma. about.com, updated April 25, 2007. Available from: http://lymphoma.about.com/od/ treatment/p/ctcltreatment.htm [Last accessed 21 September 2009]
9. Schwartz RA, Lambert WC. Cutaneous T-cell lymphoma: treatment and medication. Omaha, Nebraska, USA: medscape, updated March 19, 2009. Available from: http://emedicine.medscape.com/article/1098342-treatment [Last accessed 21 September 2009]
10. LeMaistre CF, Saleh MN, Kuzel TM, et al. Phase 1 trial of a ligand fusion-protein (DAB389IL-2) in lymphomas expressing the receptor for interleukin-2. Blood 1998;91:399-405
11. Olsen E, Duvic M, Frankel A, et al. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol 2001;19:376-388 • This was the pivotal study that the FDA reviewed, allowing approval of denileukin diftitox in therapy of mycosis fungoides. (Pubitemid 32112849)
12. Vidulich K, Jones D, Duvic M. Cutaneous gamma/δ T-cell lymphoma treated with radiation and denileukin diftitox. Clin Lymphoma Myeloma 2008;8:55-58
13. International T-cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol 2008;26:4124-4130
14. Morton LM, Wang SS, Devesa SS, et al. Lymphoma incidence patterns by WHO subtype in United States, 1992-2001. Blood 2006;107:265-276
15. The Non-Hodgkin's Lymphoma Classification Project. A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. Blood 1997;89:3909-3918
16. Eklund JW, Weller E, Kuzel TM, et al. Phase II study of denileukin diftitox for previously treated low grade non-Hodgkin's lymphoma: E1497 final report. ASCO Annual Meeting Proceedings. J Clin Oncol 2005;23(Suppl 1):6684
17. Wong BY, Ma Y, Fitzwilson R, Dang NH. De novo maintenance therapy with denileukin diftitox (Ontak®) in a patient with peripheral T-cell lymphoma is associated with prolonged remission. Am J Hematol 2008;83:596-598 (Pubitemid 351874881)
18. LeMaistre CF, Meneghetti C, Rosenblum M, et al. Phase I trial of an interleukin-2 (IL-2) fusion toxin (DAB486IL-2) in hematologic malignancies expressing the IL-2 receptor. Blood 1992;79:2547-2554
19. Wainscoat B, Salas C, Rich JD. Human T-cell lymphotrophic viruses. Omaha, Nebraska, USA: Medscape, updated Jul 13, 2006. Available from: http://emedicine.medscape.com/article/219285-overview [Last accessed 21 September 2009]
20. Di Venuti G, Nawgiri R, Foss F. Denileukin diftitox and hyper-CVAD in treatment of human T-cell lymphotropic virus 1-associated acute T-cell leukemia/lymphoma. Clin Lymphoma Myeloma 2003;4:176-178 (Pubitemid 38128682)
21. American Cancer Society. Cancer Facts and Figures 2008. American Cancer Society: Atlanta 2008. Available from: http://www.cancer.org/downloads/STT/ 2008CAFFfinalsecured.pdf [Last accessed 21 September 2009]
22. Frankel AE, Fleming DR, Powell BL, Gartenhaus R. DAB389IL-2 (Ontak) fusion protein therapy of chronic lymphocytic leukemia. Expert Opin Biol Ther 2003;3:179-186 (Pubitemid 36193660)
23. Lilly M, Kuriakose P, Turturro F, et al. A phase II study of denileukin diftitox (Ontak) in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia. ASCO Annual Meeting Proceedings. J Clin Oncol 2005;23(Suppl 1):6649
24. Frankel AE, Surendranathan A, Black JH, et al. Phase II clinical studies of denileukin diftitox diphtheria toxin fusion protein in patients with previously treated chronic lymphocytic leukemia. Cancer 2006;106:2158-2164 (Pubitemid 43673237)
25. Non-Hodgkin's Lymphoma. National Cancer Institute: US National Institutes of Health 2009. Available from: www.cancer.gov/cancertopics/types/non-hodgkin. [Last accessed 21 September 2009]
26. Kuzel TM. DAB389IL-2 (Denileukin diftitox, Ontak): review of clinical trials date. Clin Lymphoma 2000;1(Suppl 1):S33-6
27. Dang NH, Hagemeister FB, Pro B, et al. Phase II study of Denileukin Diftitox for relapsed/refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol 2004;22:4095-4102 • This study suggested that B-cell lymphomas can also be treated with denileukin diftitox with minimal toxicity. (Pubitemid 41185178)
28. Dang NH, Fayad L, McLaughlin P, et al. Phase II trial of the combination of denileukin diftitox and rituximab for relapsed/refractory B-cell NHL. Br J Haematol 2007;138:502-505 (Pubitemid 47063035)
29. Rasku MA, Clem AL, Telang S, et al. Transient T cell depletion causes regression of melanoma metastasis. J Transl Med 2008;6:12 (Pubitemid 351597459)
30. Mahnke K, Schonfeld K, Fondel S, et al. Depletion of CD4+CD25+ human regulatory T cells in vivo: kinetics of Treg depletion and alterations in immune functions in vivo and in vitro. Int J Cancer 2007;120(12):2723-2733 (Pubitemid 46651297)
31. Attia P, Maker AV, Haworth LR, et al. Inability of fusion protein of IL-2 and diphtheria toxin (Denileukin Diftitox, DAB389IL-2, ONTAK) to eliminate regulatory T lymphocytes in patients with melanoma. J Immunother 2005;28(6):582-592 (Pubitemid 41533092)
32. Ruter J, Barnett BG, Kryczek I, et al. Altering regulatory T cell function in cancer immunotherapy: a novel means to boost the efficacy of cancer vaccines. Front Biosci 2009;14:1761-1770
33. Barnett B, Kryczek I, Cheng P, et al. Regulatory T cells in ovarian cancer: biology and therapeutic potential. Am J Reprod Immunol 2005;54(6):369-377 (Pubitemid 41748714)
34. LeMaistre CF. DAB389IL-2 (Denileukin diftitox, Ontak): other potential uses. Clin Lymphoma 2000;l(Suppl 1):S37-40
35. Shaughnessy PJ, Bachier C, Grimly M, et al. Denileukin diftitox for treatment of steroid-resistant acute graft-vs-host disease. Biol Blood Marrow Transplant 2005;11:188-93 • In this study, resistant graft-versus-host disease could be treated with Ontak, adding to the list of treatment options for patients with graft-versus-host post transplant. (Pubitemid 40287917)
36. Martin A, Gutierrez E, Muglia J, et al. A multicenter dose-escalation trial with denileukin diftitox (ONTAK, DAB389IL-2) in patients with severe psoriasis. J Am Acad Dermatol 2001;45:871-881 (Pubitemid 33096627)
37. Kim BH, Yoon JH, Myung SJ, et al. Enhanced interleukin-2 diphtheria toxin conjugate-induced growth suppression in retinoic acid-treated hypoxic hepatocellular carcinoma cells. Cancer Lett 2009;274:259-265