A phase 2 study of high-dose Allovectin-7 in patients with advanced metastatic melanoma

Melanoma Research

Volumn 20, Issue 3, 2010, Pages 218-226

  Bedikian, Agop Y ^a   Richards, Jon ^b   Kharkevitch, Dmitri ^c   Atkins, Michael B ^d   Whitman, Eric ^e   Gonzalez, Rene ^f  

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

^b Oncology Specialists   (United States)

^c VICAL INC   (United States)

^d BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^e Atlantic Melanoma Center   (United States)

^f UNIVERSITY OF COLORADO   (United States)

Author keywords

Allovectin 7; Clinical trial; Human leukocyte antigen B7 and 2 microglobulin genes; Immunotherapy; Metastatic melanoma; Phase 2; Plasmid DNA

Indexed keywords

ALLOVECTIN 7; IMMUNOMODULATING AGENT; UNCLASSIFIED DRUG; ALLOVECTIN-7; LIPID; RECOMBINANT DNA;

ADULT; AGED; ARTHRALGIA; ARTICLE; CANCER GROWTH; CANCER STAGING; CANCER SURGERY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; FATIGUE; FEMALE; FEVER; HISTOPATHOLOGY; HUMAN; INJECTION SITE BLEEDING; INJECTION SITE CONTUSION; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; OUTCOME ASSESSMENT; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RIGOR; DOSE RESPONSE; IMMUNOTHERAPY; MIDDLE AGED; PROCEDURES; SKIN NEOPLASMS; STATISTICAL MODEL; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; DNA, RECOMBINANT; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; IMMUNOTHERAPY; LIPIDS; MALE; MELANOMA; MIDDLE AGED; MODELS, STATISTICAL; NEOPLASM METASTASIS; SKIN NEOPLASMS; TREATMENT OUTCOME;

EID: 77952238515     PISSN: 09608931     EISSN: None     Source Type: Journal    
DOI: 10.1097/CMR.0b013e3283390711     Document Type: Article

References (29)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin 2007;57:43-66.
2. Weber J. Review: anti-CTLA-4 antibody ipilimumab: case studies of clinical response and immune-related adverse events. Oncologist 2007;12:864-872.
3. Atkins MB. The treatment of metastatic melanoma with chemotherapy and biologics. Curr Opin Oncol 1997;9:205-213.
4. Sober AJ. Cutaneous melanoma: opportunity for cure. CA Cancer J Clin 1991;41:197-199.
5. Bayer. DTIC-Dome (dacarbazine); Physicians' Desk Reference 2004;58:857-858.
6. Chiron. Proleukin (aldesleukin); Physicians' Desk Reference 2006;60:1007-1011.
7. Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, et al. Phase III multicenter randomized trial of the Dartmouth Regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol 1999;17:2745-2751.
8. Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, et al. Randomized phase III study of temozolomide versus darcarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol 2000;18:158-166.
9. Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, et al.; The Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma. J Clin Oncol 2006;24:4738-4745.
10. NCCN Practice Guidelines in Oncology, Melanoma, V.1.2009. Available online through http://www.nccn.org, [Accessed 01 October 2008].
11. Atkins MB, Lotze M, Ducher J, Fisher RI, Weiss G, Margolin K, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol 1999;17:2105-2116.
12. Korn EL, Liu PY, Lee SJ, Chapman JA, Niedzwiecki D, Suman VJ, Kirkwood JM. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 2008;26:527-534.
13. Plautz G, Yang Z, Wu B, Gia X, Huang L, Nabel G. Immunotherapy of malignancy by in vivo gene transfer into tumors. Proc Natl Acad Sci USA 1993;90:4645-4649. (Pubitemid 23148962)
14. Nabel GJ, Nabel EG, Yang ZY, Fox BA, Plautz GE, Gao X, et al. Direct gene transfer with DNA-liposome complexes in melanoma: expression, biologic activity, and lack of toxicity in humans. Proc Natl Acad Sci USA 1993;90:11307-11311.
15. Nabel GJ, Gordon D, Bishop DK, Nickoloff BJ, Yang Z, Aruga A, et al. Immune response in human melanoma after transfer of an allogeneic class I major histocompatibility complex gene with DNA-liposome complexes. Proc Natl Acad Sci USA 1996;93:15388-15393.
16. Stopeck AT, Hersh EM, Akporiaye ET, Harris DT, Grogan T, Unger E, et al. Phase I trial of direct gene transfer of an allogeneic histocompatibility antigen, HLA-B7, in patients with metastatic melanoma. J Clin Oncol 1997;15:341-349.
17. Restifo N, Marincola F, Yutaka K, Taubenberger J, Yannelli J, Rosenberg S. Loss of functional beta2-microglobulin in metastatic melanomas from five patients receiving immunotherapy. J Nat Cancer Inst 1996;88:100-108.
18. Rini B, Selk L, Vogelzang N. Phase I study of direct intralesional gene transfer of HLA-B7 into metastatic renal carcinoma lesions. Clin Cancer Res 1999;5:2766.
19. Ruben J, Galanis E, Pitot HC, Richardson RL, Burch PA, Charboneau JW, et al. Phase I study of immunotherapy of hepatic metastases of colorectal carcinoma by direct gene transfer of an allogeneic histocompatibility antigen, HLA-B7. Gene Therapy 1997;4:419.
20. Horton HM, Dorigo O, Hernandez P, Anderson D, Berek JS, Parker SE. IL-2 plasmid therapy of murine ovarian carcinoma inhibits the growth of tumor ascites and alters its cytokine profile. J Immunol 1999;163:6378-6385.
21. DeBruyne LA, Chang AE, Cameron MJ, Yang Z, Gordon D, Nabel EG, et al. Direct transfer of a foreign MHC gene into human melanoma alters T-cell receptor V beta usage by tumor-infiltrating lymphocytes. Cancer Immunol Immunother 1996;43:49-58.
22. Stopeck A, Jones A, Hersh E, Thompson JA, Finucane DM, Gutheil JC, Gonzalez R. Phase II study of direct intralesional gene transfer of Allovectin-7, a HLA-B7/beta2-microglobulin DNA-liposome complex, in patients with metastatic melanoma. Clin Cancer Res 2001;7:2285-2291.
23. Gutheil J, Atkins MB, Schwarzenberger P, Lutzky J, Rubin J, Deisseroth A, et al. Phase II trial of HLA-B7 plasmid DNA/lipid (Allovectin-7) immunotherapy in patients with metastatic melanoma. Eur J Cancer 2001;37(Suppl 6):160.
24. Richards J, Bedikian A, Gonzalez R, Atkins MB, Whitman E, Lutzky J, et al. A phase 2 trial of high-dose Allovectin-7 in patients with advanced metastatic melanoma. J Clin Oncol 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition), Abs 7509. 2004;22, No 14 S (July 15 Supplement).
25. Therasse P, Arbuck S, Eisenhauer E, Wanders J, Kaplan R, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-216. (Pubitemid 30099779)
26. Bedikian AY, del Vecchio M. Allovectin-7 therapy in metastatic melanoma. Expert Opin Biol Ther 2008;8:839-844.
27. Gonzalez R, Hutchins L, Nemunaitis J, Atkins M, Schwarzenberger PO. Phase 2 trial of Allovectin-7 in advanced metastatic melanoma. Melanoma Res 2006;16:521-526.
28. Hodi FS, Hoos A, Ibrahim R, Chin K, Pehamberger H, Harmankaya K, et al. Novel efficacy criteria for antitumor activity to immunotherapy using the example of ipilimumab, an anti-CTLA-4 monoclonal antibody. J Clin Oncol 2008;26:3008.
29. Steitz J, Bruck J, Lenz J, Buchs S, Tuting T. Peripheral CD8 + Tcell tolerance against melanocytic self-antigens in the skin is regulated in two steps by CD4 + T cells and local inflammation: implications for the pathophysiology of vitiligo. J Inv Derm 2005;124:144-150.