Efficacy and safety of HLA-B7/β-2 microglobulin plasmid DNA/lipid complex (Allovectin-7®) in patients with metastatic melanoma

Expert Opinion on Biological Therapy

Volumn 3, Issue 2, 2003, Pages 377-384

  Bergen, Michael ^a,b   Chen, Robert ^a   Gonzalez, Rene ^a  

^a UNIVERSITY OF COLORADO CANCER CENTER   (United States)

^b Anschutz Cancer Pavilion   (United States)

Author keywords

Allovectin 7; Beta 2 microglobulin; Gene therapy; HLA B7, major histocompatibility complex; Melanoma; Plasmid DNA lipid complex; Vaccine

Indexed keywords

ALLOVECTIN 7; ALPHA INTERFERON; BETA 2 MICROGLOBULIN; CARMUSTINE; CISPLATIN; CYCLOPHOSPHAMIDE; DACARBAZINE; FLUDARABINE; GANGLIOSIDE GM2; HLA B7 ANTIGEN; INTERLEUKIN 2; KEYHOLE LIMPET HEMOCYANIN; LIPID; MELANOMA VACCINE; PLASMID DNA; TAMOXIFEN; UNCLASSIFIED DRUG; VINBLASTINE;

ADOPTIVE TRANSFER; ANEMIA; BLEEDING; CANCER COMBINATION CHEMOTHERAPY; CANCER PREVENTION; CLINICAL TRIAL; DRUG APPROVAL; DRUG BONE LEVEL; DRUG EFFICACY; DRUG LIVER LEVEL; DRUG MEGADOSE; DRUG MUSCLE LEVEL; DRUG SAFETY; DRUG TISSUE LEVEL; DRUG TOLERABILITY; DRUG URINE LEVEL; DYSPHAGIA; EDEMA; ERYTHEMA; FOLLOW UP; GENE THERAPY; HEART ARREST; HEART FAILURE; HEMATOMA; HUMAN; HYPOTENSION; LOW DRUG DOSE; LUNG DISEASE; MAJOR HISTOCOMPATIBILITY COMPLEX; MALIGNANT NEOPLASTIC DISEASE; MELANOMA; META ANALYSIS; METASTASIS; PAIN; PLASMA HALF LIFE; PNEUMOTHORAX; REVIEW; SIDE EFFECT; SOUTHERN BLOTTING;

ANIMALS; BETA 2-MICROGLOBULIN; CLINICAL TRIALS, PHASE I; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; DNA; HLA-B7 ANTIGEN; HUMANS; LIPIDS; LIPOSOMES; MELANOMA; NEOPLASM METASTASIS; PLASMIDS;

EID: 0037391751     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/eobt.3.2.377.21150     Document Type: Review

References (56)

1. RIGEL DS, FRIEDMAN RJ, KOPF AW: The incidence of malignant melanoma in the United States: issues as we approach the 21st century. J. Am. Acad. Dermatol. (1996) 34(5 Pt 1):839-847.
2. JEMAL A, THOMAS A, MURRAY T, THUN MM: Cancer statistics 2002. CA Cancer J. Clin. (2002) 52:23-47.
3. RIGEL DS, CARUCCI JA: Malignant melanoma: prevention, early detection and prevention in the 21st century. CA Cancer J. Clin. (2000) 50:215-236.
4. HALL HI, MILLER DR, ROGERS JD, BEWERSE B: Update on the incidence and mortality from melanoma in the United States. J. Am. Acad. Dermatol. (1999) 40:35-42.
5. KIRKWOOD JM, STRAWDERMAN MH, ERNSTOFF MS, SMITH TJ, BORDEN EC, BLUM RH: Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group Trial EST 1684. J. Clin. Oncol. (1996) 14(1):7-17. The ECOG 1684 trial used 1 year of high-dose IFN and showed statistically significant overall and disease-free survival benefits for patients with lesions > 4 mm depth, or with positive lymph nodes, compared to the no additional treatment group.
6. KEILHOLZ U, EGGERMONT AM: The role of interleukin-2 in the management of stage IV melanoma; the EORTC melanoma cooperative group program. Canc. J. Sci. Am. (2000) 6(Suppl. 1):S99-S103.
7. MIDDLETON MR, GROB JJ, AARONSON N et al.: Randomized Phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J. Clin. Oncol. (2000) 18(1):158-166.
8. BRODER S, WALDMAN TA: The suppressor-cell network in cancer. N. Engl. J. Med. (1978) 299(23):1281-1284.
9. LOEFFLER CM, SMYTH MJ, LONGO DL et al.: Immunoregulation in cancer-bearing hosts. Down regulation of gene expression and cytotoxic function in CD8+ T cells. J. Immunol. (1992) 149(3):949-956.
10. HICKLIN DJ, WANG Z, ARIENTI et al.: Beta2-microglobulin mutations HLA dass I antigen loss, and tumor progression in melanoma. J. Clin. Invest. (1998) 101(12):2720-2729.
11. NOURI AM, HUSSAIN RF, DOS SA, MANSOURI M, OLIVER RT: Intensity of class I antigen expression on human tumour cell lines and its relevance to the efficiency of non-MHC-restricted killing. Br. J. Cancer (1993) 67:1223-1228.
12. TANAKA K, ISSELBACHER KJ, KHOURY G et al.: Reversal of oncogenesis by expression of a major histocompatibility complex class I gene. Science (1985) 228(4695):26-30.
13. HILL GJ, KREMENTZ ET, HILL HZ: Dimethyl triazeno imidazole carboxamide and combination therapy for melanoma. IV. Late results after complete response to chemotherapy (Central Oncology Group protocols 7130, 7131, and 7131A). Cancer (1984) 53(6):1299-1305.
14. BUZAID AC, LEGHA S, WINN R et al.: Cisplatin, vinblastine, and dacarbazine (CVD) versus dacarbazine alone in metastatic melanoma; preliminary results of a Phase II cancer community oncology program (CCOP) trial (abstract). Proc. Am. Soc. Clin. Oncol. (1993) 12:389.
15. CHAPMAN PB, EINHORN LH, MEYERS ML et al.: Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J. Clin. (1999) 17(9):2745-2751.
16. MIDDLETON MR, LORIGAN P, OWEN J et al.: A randomized Phase III study comparing dacarbazine, BCNU, cisplatin and tamoxifen with dacarbazine and interferon in advanced melanoma. Br. J. Cancer (2000) 82(6):1158-1162.
17. KIRKWOOD JM, IBRAHIM JG, SONDAK VK et al.: High- and low-dose interferon alfa-2b in high-risk melanoma: first analysis of Intergroup Trial E1690/ S9111/C9190. J. Clin. Oncol. (2000) 18(12):2444-2458.
18. WHEATLEY K, HANCOCK B, GORE M, SUCIU S, EGGERMONT AMM: Interferon-alpha as adjuvant therapy for melanoma: a metaanalysis of the randomized trials. [abstract]. Proc. Am. Soc. Clin. Oncol. (2001) 20:1394.
19. LENS MB, DAWES M: Interferon alfa therapy for malignant melanoma: a systematic review of randomized controlled trials. J. Clin. Oncol. (2002) 20:1818-1825. A somewhat controversial systematic review of most major interferon trials in melanoma.
20. KIRKWOOD JM, IBRAHIM J, ERNSTOFF MS, FLAHERTY L, HALUSKA FJ; WHEALTELY K, IVES N, HANCOCK B, GORE M; SEIDMAN AD, PIERI MK, HUDIS C; LENS MB, DAWES M: Correspondence: Need for a quantitative meta-analysis of trials of adjuvant interferon in melanoma; Replies; Use and abuse of statistics in evidence-based medicine. J. Clin. Oncol. (2002) 20:4119-4124.
21. KIRKWOOD JM, IBRAHIM JG, SOSMAN JA et al.: 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) 19:2370-2380.
22. FALKSON CI, FALKSON G, FALKSON HC: Improved results with the addition of interferon alpha-2b to dacarbazine in the treatment of patients with metastatic melanoma. J. Clin. Oncol. (1991) 9:1403-1408.
23. FALKSON CI, IBRAHIM J, KIRKWOOD JM, COATES AS, ATKINS MB, BLUM R: Phase II trial of dacarbazine versus dacarbazine with interferon alpha2b versus dacarbazine with tamoxifen in patients with metastatic malignant melanoma: an Eastern Cooperative Oncology study. J. Clin. Oncol. (1998) 16:1743-1751.
24. ATKINS MB, LOTZE MT, DUTCHER JP 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.
25. ATKINS MB, KUNKEL L, SZNOL M, ROSENBERG SA: High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J. Sci. Am. (2000) 6(Suppl. 1):S11. Larger trial using high-dose IL-2 in metastatic melanoma, resulting in 6% CRs and 4% durable CRs lasting 70+ to 150+ months.
26. ROYAL RE, STEINBERG SM, KROUSE RS et al.: Correlates of response to IL-2 therapy in patients treated for metastatic renal cancer and melanoma. Cancer J. Sci. Am. (1996) 2:91.
27. LEGHA SS, RING S, BEDIKIAN A et al.: Treatment of metastatic melanoma with combined chemotherapy containing cisplatin, vinblastine and dacarbazine and biotherapy using interlukin-2 and interferon-alpha. Ann. Oncol. (1996) 7(8):827-835.
28. MCDERMOTT DF, MEIR JW, LAWRENCE DP et al.: A Phase II pilot trial of concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin 2, and interferon alpha-2b in patients with metastatic melanoma. Clin. Cancer Res. (2000) 6(6):2201-2208.
29. LEGHA SS, RING S, ETON O et al.: Development of a biochemotherapy regimen with concurrent administration of cisplarin, vinblastine, dacarbazine, interferon alpha, and interleukin-2 for patients with metastatic melanoma. J. Clin. Oncol. (1998) 16:1752-1759. Small trial using concurrent biochemotherapy which resulted in significant response rates and 9% durable CRs in metastatic melanoma.
30. FLAHERTY LE: Rationale for Intergroup trial E-3695 comparing concurrent biochemotherapy with cisplatin, vinblastine, and DTIC alone in patients with metastatic melanoma. Cancer J. Sci. Am. (2000) 6(Suppl. 1):S15-S20.
31. NESTLE FO, BANCHEREAU J, HART D: Dendritic cells: on the move from the bench to the bedside. Nat. Med. (2001) 7:761-765.
32. ROSENBERG SA, YANG JC, SCHWARTZENTRUBER DJ et al.: Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat. Med. (1998) 4(3):321-327.
33. BELLI F, TESTORI A, RIVOLTINI L et al.: Vaccination of metastatic melanoma patients with autologous tumor-derived hear shock protein gp-96-peptide complexes: clinical and immunologic findings. J. Clin. Oncol. (2002) 20(20):4169-4180.
34. HSUEH E, ESSNER R, FOSHAG L et al.: Prolonged survival after complete resection of disseminated melanoma and active immunotherapy with a therapeutic cancer vaccine. J. Clin. Oncol. (2002) 20(23):4549-4554.
35. BANCHEREAU J, PALUCKA AK, DHODAPKAR M et al.: Immune and clinical response in patients with metastatic melanoma to CD34+ progenitor-derived dendritic cell vaccine. Cancer Res. (2000) 61:6451-6458.
36. NAWROCKI S, WYSOCKI PJ, MACKIEWICZ A: Genetically modified tumour vaccines: an obstacle race to break host tolerance to cancer. Expert Opin. Biol. Ther. (2001) 1(2):193-204.
37. ROSENBERG SA, YANNELLI JR, YANG JC, TOPALIAN SL, SCHWARTZENTRUBER DJ, WEBER JS: Treatment of patients with metastatic melanoma with autologous tumor-infiltrating lymphocytes and interleukin 2. J. Natl. Cancer Inst. (1994) 86(15):1159-1166.
38. YEE C, THOMPSON JA, ROCHE P, BYRD DR, LEE PP, PIEPKORN M: Melanocyte destruction after antigenspecific immunotherapy of melanoma: direct evidence of T cell-mediated vitiligo. J. Exp. Med. (2000) 192(11):1637-1644.
39. DUDLEY ME, WUNDERLICH J, NISHIMURA MI et al.: Adoptive transfer of cloned melanoma-reactive T lymphocytes for the treatment of patients with metastatic melanoma. J. Immunother. (2001) 24(4):363-373.
40. DUDLEY ME, WUNDERLICH JR, YANG JC, HWU P, SCHWARTZENTRUBER DJ, TOPALIAN SL: A Phase I study of nonmyeloablative chemotherapy and adoptive transfer of autologous tumor antigen-specific T lymphocytes in patients with metastatic melanoma. J. Immunother. (2002) 25(3):243-251.
41. DUDLEY ME, WUNDERLICH JR, ROBBINS PF et al.: Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science (2002) 298(5594):850-854.
42. NAWROCKI S, MURAWA P, MALICKI J et al.: Genetically modified tumour vaccines (GMTV) in melanoma clinical trials. Immunol. Lett. (2000) 74(1):81-86.
43. PHILIP PA, FLAHERY LE: Biochemotherapy for melanoma. Curr. Oncol. Rep. (2000) 2(4):314-321.
44. ATKINS MB: The treatment of melanoma with chemotherapy and biologics. Curr. Opin. Oncol. (1997) 9(2):205-213.
45. LEE ML, TOMSU K, VON ESCHEN KB: Duration of survival for disseminated malignant melanoma: results of a meta-analysis. Melanoma Res. (2000) 10(1):81-92.
46. WAGNER JD, GORDON MS, CHUANG TY, COLEMAN JJ 3RD: Current therapy of cutaneous melanoma. Plast. Reconstr. Surg. (2000) 105(5):1774-1799.
47. PARKER SE, VAHLSING HL, SERFILIPPI LM et al.: Cancer gene therapy using plasmid DNA: safety evaluation in rodents and non-human primates. Hum. Gene Ther. (1995) 6(5):575-590.
48. LEW D, PARKER SE, LATIMER T et al.: Cancer gene therapy using plasmid DNA: pharmacokinetic study of DNA following injection in mice. Hum. Gene. Ther. (1995) 6(5):553-564.
49. PARKER SE, DUCHARME S, NORMAN J, WHEELER CJ: Tissue distribution of the cytofectin component of a plasmid-DNA/cationic lipid complex following intravenous administration in mice. Hum. Gene Ther. (1997) 8(4):393-441.
50. STOPECK AT, HERSH EM, AKPORIAYE ET et al.: Phase I study of direct gene transfer of an allogeneic histocompatibility antigen, HLA-B7, in patients with metastatic melanoma. J. Clin. Oncol. (1997) 15:341-349.
51. NABEL G, NABEL E, YANG Z 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.
52. NABEL G, GORDON D, BISHOP DK 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.
53. SILVER HKB, KLASA RJ, BALLY JB et al.: Phase I gene therapy study of HLA-B7 transduction by direct injection in malignant melanoma. Proc. AACR (1996) 37(342):3227 (Abstract).
54. HERSH EM, FIGLIN R, GUTHEIL J et al.: Intratumoral gene transfer therapy of cancer. Mol. Ther. (2001) 3(5 Suppl.):S19.
55. RICHARDS J, THOMPSON J, ATKINS MB et al.: A controlled, randomized Phase III trial comparing the response to dacarbazine with and without Allovectin-7 in patients with metastatic melanoma. ASCO Abstracts (2002):#1380.
56. STOPECK AT, JONES A, HERSH EM et al.: Phase II study of direct intralesional gene transfer of Allovectin-7, and HLA-B7/ B2-microglobulin DNA-liposome complex, in patients with metastatic melanoma. Clin. Cancer Res. (2001) 7:2285-2291. Small trial using Allovectin-7 in patients with metastatic melanoma, resulting in an overall response rate of 4% and stable disease in 18% lasting at least 11 weeks, with a relatively safe toxicity profile outside the adverse events experienced with intracavitary injections.