Heterophilic NeuGcGM3 ganglioside cancer vaccine in advanced melanoma patients: Results of a Phase Ib/IIa study

Cancer Biology and Therapy

Volumn 7, Issue 4, 2008, Pages 488-495

  Osorio, Marta ^a   Gracia, Elías ^a   Rodríguez, Edmundo ^a   Saurez, Giselle ^b   Arango, Maria Del Carmen ^a   Noris, Elena ^a   Torriella, Adriana ^a   Joan, Alejandro ^a   Gómez, Erasmo ^a   Anasagasti, Lorenzo ^a   González, Jorge Luis ^a   Melgares, María De Los Angeles ^a   Torres, Imilla ^a   González, Joel ^a   Alonso, Dayamí ^a   Rengifo, Enrique ^b   Carr, Adriana ^b   Pérez, Rolando ^b   Fernández, Luis Enrique ^b  

^a INSTITUTO NACIONAL DE ONCOLOGÍA Y RADIOBIOLOGÍA   (Cuba)

^b CENTER OF MOLECULAR IMMUNOLOGY   (Cuba)

Author keywords

Autoimmunity; Cancer vaccines; Clinical trial; Gangliosides; Melanoma; NeuGcGM3; Vitiligo

Indexed keywords

CANCER VACCINE; DIPHENHYDRAMINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIDERMAL GROWTH FACTOR RECEPTOR ANTIBODY; GANGLIOSIDE; IMMUNOGLOBULIN A ANTIBODY; IMMUNOGLOBULIN M; MONTANIDE ISA 51; PARACETAMOL;

ABDOMINAL PAIN; ADJUVANT THERAPY; ADULT; ADVANCED CANCER; ANOREXIA; ARTICLE; ASTHENIA; AUTOIMMUNITY; CANCER IMMUNIZATION; CANCER LOCALIZATION; CANCER SURVIVAL; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DEPIGMENTATION; DRUG SAFETY; ERYTHEMA; FEMALE; FEVER; HEADACHE; HUMAN; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE REACTION; LEUKOPENIA; MALE; MELANOCYTE; MELANOMA; MYALGIA; NAUSEA AND VOMITING; NEISSERIA MENINGITIDIS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PROPHYLAXIS; PROTEIN EXPRESSION; PROTEOLIPOSOME; SIDE EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE; VITILIGO;

EID: 45349091152     PISSN: 15384047     EISSN: 15558576     Source Type: Journal    
DOI: 10.4161/cbt.7.4.5476     Document Type: Article

References (50)

1. Meyskens FL., Management of Human Melanoma: What the last decade wrought? The Oncologist 2003; 8:448-50.
2. th Annual Meeting of the American Society of Clinical Oncology, 2002.
3. Morton DL, Essner R, Kirkwood JM, and Wollman RC. Malignant Melanoma in Cancer. Holland JF and Frei E. Cancer medicine review, Section 34; p 1849-69. 5th ed. Hamilton, Ont.; London: BC Decker, 2000.
4. Tsao H, Atkins MB, Sober AJ. Management of Cutaneous Melanoma. N Engl J Med 2004; 351:998-1012.
5. Chung MH, Gupta RK, Hsueh E, Essner R, Ye W, Yee R, Morton DL. Humoral Immune response to a Therapeutic polyvalent Cancer vaccine after Complete Resection of Thick primary Melanoma and sentinel Lymphadenectomy. J Clin Oncol 2003; 21:313-19.
6. Hersey P. Immunotherapy of non- resected melanoma. In: Thompson JF, Morton DL and Kroon BB. Editors. Text Book of Melanoma. First edition. London and New York Martin Dunitz 2004; 602-9.
7. Hakomori S: Aberrant Glycosilation in cancer cell membranes as focused on glycolipids: Overview and perspectives. Cancer Res 1985; 45:2405-14.
8. Zhang S, Cordon Cardo C, Zhang HS, Reuter VE, Adluri S Hamilton WB, O. Lloyd K, Livingston PO. Selection of Carbohydrate Tumor antigen as targets for immune attack using immunohistochemistry: I. Focus on gangliosides. Int J Cancer 1997; 73:42-9.
9. Doré JD, Pourtokalian J, Berthier Vergnes O, Jacubovich R, Genève J, Bailly M, Lefthériotis E, Weissbrod A, Mayer M. Réponse des malades atteints de mélanome a l'immunisation par oncolisats de mélanome au virus de la vaccine. Bull Cancer 1990; 77:881-91.
10. Nakarai H, Chandler PJ, Kano K, Morton DL, Irie RF. Hanganutziu-Deicher 8 HD) antigen as a possible target for immunotherapy of melanoma. Int.Arch Allergy Appl Immunol 1990; 91:323-28.
11. Kawachi S, Saida T. Analysis of the expression of Hanganutziu-Deicher (HD) antigen in human malignant melanoma J Dermatol 1992; 19:827-30.
12. Carr A, Mullet A, Mazorra Z, Vázquez AM, Alfonso M, Mesa C, Rengifo E, Pérez R, Fernández LE. A mouse IgG 1 monoclonal antibody specific for N-Glycolyl GM3 ganglioside recognized breast and melanoma tumors. Hybridoma 2000; 19:241-47.
13. Malykh YN, Schauer R, Shaw L. N-Glycolylneuraminic acid in human tumours Biochimie 2001; 83:623-34.
14. De Leon J, Fernandez A, Mesa C, Clavel M and Fernandez LE. Role of tumor associated N-Glycolilated variant of GM3 ganglioside in cancer progression effect over CD4 expression on T cells. Cancer Imm Immunotherapy 2006; 55:443-50.
15. Carr A, Rodriguez E, Arango MC, Camacho R, Osorio M, Gabri M, Carrillo G, Valdés Z, Bebelagua Y, Pérez R, Fernández LE. Immunotherapy of Advanced Breast Cancer with a Heterophilic Ganglioside (NeuGcGM3) Cancer Vaccine. J Clin Oncol 2003; 21:1015-21.
16. Estevez F, Carr A, Solórzano L, Valiente O, Mesa C, Barroso O, Sierra GV, Fernandez LE. Enhancement of the immune response to poorly immunogenic gangliosides after incorporation into very small size proteoliposomes (VSSP) Vaccine 2000; 18:190-7.
17. Mesa C, de León J, Rigley K, Fernández LE. Very small size proteoliposomes derived from Neisseria meningitidis: an effective adjuvant for Th1 induction and dendritic cell activation. Vaccine 2004; 22:3045-52.
18. NCI Common Toxicity Criteria (CTC) version 2.0 Final 1998.
19. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New Guidelines to evaluate the response to treatment in solid tumors. J Ntl Cancer Inst 2000; 92:205-16.
20. Balch C, Buzaid A, Atkins M, Cascinelli N, Coit DG, Fleming ID, Houghton A, Kirkwood JM, Mihm MF, Morton DL, Reintgen D, Ross MI, Sober A, Soong SJ, Thompson JA, Thompson JF, Gershenwald JE, McMasters KM. A new American Joint Committee on cancer staging system for cutaneous melanoma. Cancer 2000; 88:1484-91.
21. Hsu SM, Raine L, and Fanger H. Use the avidin-biotin - peroxidase complex (ABC) in immunoperoxidase technique: a comparison between ABC and unlabelled antibody PAP procedures. J Histochem Cytochem 1989; 29:577-80.
22. Folch PJ, Arsove S, Meath JA. Isolation of brain stradin, a new type of large molecular tissue component. J Biol Chem 1957; 226:497-509.
23. Miller Podraza H, Månsson JE, Svennerholm L. Isolation of complex gangliosides from human brain. Biochim Biophys Acta 1992; 1124:45-51.
24. Fredman P, Nilsson O, Tayot JL, Svennerholm L. Separation of gangliosides on a new type of anion-exchange resin. Biochim Biophys Acta 1980; 618:42-52.
25. Kawai K, Kuroda S, Watarai S, Takahashi H and Ikuta F. Occurrence of GD3 gangliosides in reactive astrocytes - an immunocychemical study in the rat brain. Neuroscience Lett 1994; 174:119-24.
26. Tangvoranuntakul P, Gagneux P, Diaz S, Bardor M, Varki N, Varki A, Muchmore E.Human uptake and incorporation of an immunogenic nonhuman dietary sialic acid. Proc Natl Acad Sci USA 2003; 21:12045-50.
27. Lowell GH, Smith LF, Seid RC, and Zollinger WD. Peptides bound to proteosomes via hydrophobic feet become highly immunogenic witout adjuvants. J Exp Med 1988; 167:658-63.
28. Carr A, Mazorra Z, Alonso DF, Mesa C, Valiente O, Gomez DE, Perez R and Fernandez LE. A purifed GM3 ganglioside conjugated vaccine induces specific, adjuvant-dependent and nontransient antitumour activity against B16 mouse melanoma in vitro and in vivo Melanoma Research 2001; 11:219-27.
29. Livingston PO, Calves MJ, Helling F, Zollinger WD, Blake MS, Lowell GH. GD3/proteosome vaccines induce consistent IgM antibodies against the ganglioside GD3. Vaccine 1993; 11:1199-204.
30. Aucouturier J, Dupuis L, Deville S, Ascarateil S, and Ganne V. Montanide ISA 720 and 51: a new generation of water in oil emulsions as adjuvants for human vaccines. Expert Rev Vaccines 2002; 1:111-18.
31. Bada AM, Casacó A, Mancebo A, Fuentes D, Gonzalez B, Hernández O, Subirós N, Arteaga M, Hernández J, Carr A and Fernández LE. Acute and Repeated Dose Intramuscular Toxicity of GM3 cancer vaccine in SD rats Pakistan Journal of Biological Sciences 2005; 8:1045-50.
32. Bada A, Casaco A, Arteaga M, Martínez J, León A, Santana E, Hernández O, Orphee R, González A, Mesa C, González C, Montero E, Fernández LE. Toxicity of a GM3 cancer vaccine in Macaca fascicularis monkey: a 12 month study. Human and Experimental Toxicology 2002; 21:263-67.
33. Portoukalian J, Carrel S, Doré JF, Rümke P. Humoral immune response in disease-free advanced melanoma patients after vaccination with melanoma-associated gangliosides. EORTC Cooperative Melanoma Group. Int J Cancer 1991; 49:893-9.
34. Frey AB, Monu N. Effector-phase tolerance: another mechanism of how cancer escapes antitumor immune response. J Leukoc Biol 2006; 79:652-62.
35. Ravindranath MH, Muthugounder S, Hannah MR, Morton DL. Significance of endogenous augmentation of antiganglioside IgM in cancer patients: potential tool for early detection and management of cancer therapy. Ann N Y Acad Sci 2007; 1107:212-22.
36. Kotelianskiî EO. Immunoglobulins M, G and A as prognostic criteria of the treatment outcome in uveal melanoblastoma Allerg Immunol (Leipz) 1981; 27:14-21.
37. Luiten RM, Kueter EW, Mooi W, Gallee MP, Rankin EM, Gerritsen WR, Clift SM, Nooijen WJ, Weder P, van de Kasteele WF, Sein J, van den Berk PC, Nieweg OE, Berns AM, Spits H, de Gast GC. Immunogenicity, including vitiligo, and feasibility of vaccination with autologous GM-CSF-transduced tumor cells in metastatic melanoma patients. J Clin Oncol 2005; 23:8978-91.
38. Yang JC, Sherry RM, Steinberg SM, Topalian SL, Schwartzentruber DJ, Hwu P, Seipp CA, Rogers Freezer L, Morton KE, White DE, Liewehr DJ, Merino MJ, Rosenberg SA. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol 2003; 16:3127-32.
39. Gogas H, Loannovich J, Dafni U, Stavropoulou Giokas C, Frangia K, Tsoutsos D, Panagiotou P, Polyzos A, Papadopoulos O, Stratigos A, Markopoulos C, Bafaloukos D, Pectasides D, Fountzilas G, Kirkwood JM. Prognostic significance of autoimmunity during treatment of melanoma with interferon. N Engl J Med 2006; 354:709-18.
40. Boasberg PD, Hoon DSB, Piro LD, Martin MA, Fujimoto A, Kristedja TS, Bhachu S, Ye X, Deck RR, and O'Day SJ. Enhanced survival associated with vitiligo expression during maintenance biotherapy for metastatic melanoma. J of Investigative Dermatology 2006; 126:2658-63.
41. Rosenberg SA, White DE, Vitiligo in Patients with melanoma: normal tissue antigens can be targets for cancer immunotherapy. J Immunother Emphasis Tumor Immunol 1996; 19:81-4.
42. Kirkwood JM, Ibrahim JG, Sondak V, Kagarwala SS, Ernstoff MS, Rao U. High-dose interferon alfa-2b significantly prolongs relapse-free and overall survival compared with the GM2-KLH/QS-21 vaccine in patients with resected stage IIB-III melanoma: results of intergroup trial E1694/S9512/C509801. J Clin Oncol 2001; 19:2370-80.
43. Rocha IM, Oliveira LJ, De Castro LC, de Araújo Pereira LI, Chaul A, Guerra JG, Silvestre MC, Batista KM, Pereira FA, Gomide MA, Guillo LA.. Recognition of melanoma cell antigens with antibodies present in sera from patients with vitiligo. Int J Dermatol 2000; 39:840-3.
44. Das PK, Van der Wijngaard RM, Wankovicz Kalinska A, Le Poole IC. A symbiotic concept of autoimmunity and tumour immunity: lessons from Vitiligo. Trends Immunol 2001; 22:1306.
45. Merimsky O, Shoenfeld Y, Baharav E, Zigelman R, Fishman P. Reactivity to tirosinase: expression in cancer (melanoma) and autoimmunity (vitiligo). Hum Antibodies Hybridomas 1996; 7:151-6.
46. Merimsky O, ShoenfeldY, Fishman P. The clinical significance of antitirosinase antibodies in melanoma and related hypopigmentary lesions. Clin Rev Allergy Immunol 1998; 16:227-36.
47. Yee C, Thompson JA, Roche P, Byrd DR, Lee PP, Piepkorn M, Kenyon K, Davis MM, Riddell SR, Greenberg PD. Melanocyte Destruction after Antigen-specific Immunotherapy of Melanoma: Direct Evidence of T Cell-mediated Vitiligo. J Exp Med 2000; 192:1637-43.
48. Ongenae K, Van Geel N, Naeyert JM. Evidence for an Autoimmune Pathogenesis of Vitiligo. Pigment Cell Res 2003; 16:90-100.
49. Huang CL, Nordlung JJ, Boissy R. Vitiligo. A manifestation of apoptosis. Am J Clin Dermatol 2002; 3:301-8.
50. Phan GQ, Yang JC, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, Restifo NP, Haworth LR, Seipp CA, Freezer LJ, Morton KE, Mavroukakis SA, Duray PH, Steinberg SM, Allison JP, Davis TA, Rosenberg SA. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associate antigen blockade in patients with metastatic melanoma. Proc Natl Acad Sci USA 2003; 100:8372-7.