TNFerade biologic, an adenovector with a radiation-inducible promoter, carrying the human tumor necrosis factor alpha gene: A phase I study in patients with solid tumors

Journal of Clinical Oncology

Volumn 22, Issue 4, 2004, Pages 592-601

  Senzer, Neil ^a   Mani, Sridhar ^a   Rosemurgy, Alexander ^a   Nemunaitis, John ^a   Cunningham, Casey ^a   Guha, Chandan ^a   Bayol, Natalia ^a   Gillen, Michelle ^a   Chu, Karen ^a   Rasmussen, Camilla ^a   Rasmussen, Henrik ^a   Kufe, Donald ^a   Weichselbaum, Ralph ^a   Hanna, Nader ^a  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; TUMOR NECROSIS FACTOR ALPHA; ANTINEOPLASTIC AGENT;

ARTICLE; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEVER; GENE VECTOR; HUMAN; INJECTION PAIN; MAJOR CLINICAL STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SOLID TUMOR; ADENOVIRUS; ADULT; AGED; DOSE RESPONSE; FEMALE; GENE EXPRESSION REGULATION; GENE TRANSFER; GENETICS; MALE; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; NEOPLASM; PROMOTER REGION; RADIATION EXPOSURE; RADIOTHERAPY;

ADENOVIRIDAE; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; COMBINED MODALITY THERAPY; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GENE EXPRESSION REGULATION, NEOPLASTIC; GENE TRANSFER TECHNIQUES; GENETIC VECTORS; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PROMOTER REGIONS (GENETICS); RADIOTHERAPY; TUMOR NECROSIS FACTOR-ALPHA;

EID: 1442332187     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2004.01.227     Document Type: Article

References (46)

1. Balkwell FR, Lee A, Aldam G, et al: Human tumor xenografts treated with recombinant human tumor necrosis factor alone or in combination with interferon. Cancer Res 46:3990-3993, 1996
2. Asher A, Mule JJ, Reichert CM, et al: Studies on the anti-tumor efficacy of systemically administered recombinant tumor necrosis factor against several murine tumors in vivo. J Immunol 138:963-974, 1987
3. Creasey AA, Reynolds MT, Laird W: Cures and partial regression of murine and human tumors by recombinant human tumor necrosis factor. Cancer Res 46:5687-5690, 1986
4. Fukumura D, Salehi HA: Witwer B, et al: Tumor necrosis factor alpha-induced leukocyte adhesion in normal and tumor vessels: Effect of tumor type, transplantation site, and host strain. Cancer Res 55:4824-4829, 1995
5. Gamm H, Lindemann A, Metersmann, et al: Phase I trial of recombinant human tumor necrosis factor a in patients with advanced malignancy. Eur J Cancer 27: 856-863, 1991
6. Hallahan DE, Vokes EE Rubin SJ, et al: Phase I dose-escalation study of tumor necrosis factor-alpha and concomitant radiation therapy. Cancer J Sci Am 1:204-209, 1995
7. Chapman PB, Lester TJ, Casper ES, et al: Clinical pharmacology of human tumor necrosis factor in patients with advanced cancer. J Clin Oncol 5:1942-1951, 1987
8. Feinberg B, Kurzrock R, Talpaz M., et al: A phase I trial of intravenously administered recombinant tumor necrosis factor-alpha in cancer patients. J Clin Oncol 6:1328-1334, 1988
9. Spriggs DR, Sherman ML, Michie H, et al: Recombinant tumor necrosis factor administered as a 24-hour intravenous infusion. A phase I and pharmacologic study. J Natl Cancer Inst 80:1039-1044, 1988
10. Lienard D, Ewalenko P, Delmotte JJ, et al: High-dose recombinant tumor necrosis factor alpha in combination with interferon gamma and melphalan in isolation perfusion of the limbs for melanoma and sarcoma. J Clin Oncol 10:52-60, 1992
11. Thom AK, Alexander HR, Andrich MP, et al: Cytokine levels and systemic toxicity in patients undergoing isolated limb perfusion with high-dose tumor necrosis factor, interferon gamma, and melphalan. J Clin Oncol 13:264-273, 1995
12. Marr RA, Hitt M, Muller WJ, et al: Tumour therapy in mice using adenovirus vectors expressing human TNFα. Int J Oncol 12:509-515, 1998
13. Marr RA, Hitt M, Gauldie J, et al: A p75 tumor necrosis factor receptor-specific mutant of murine tumor necrosis factor alpha expressed from an adenovirus vector induces an antitumor response with reduced toxicity. Cancer Gene Ther 6:465-474, 1999
14. Hallahan DE, Mauceri JJ, Seung LP, et al: Spatial and temporal control of gene therapy using ionizing radiation. Nat Med 1:786-791, 1995
15. Chung T, Mauceri HJ, Hallahan DE, et al: Tumor necrosis factor-α-based gene therapy enhances radiation cytotoxicity in human prostate cancer. Cancer Gene Ther 5:344-349, 1998
16. Staba MJ, Mauceri HJ, Kufe DW, et al: Adenoviral TNFα gene therapy and radiation damage tumor vasculature in a human malignant glioma xenograft. Gene Ther 5:293-300, 1988
17. Gupta VK, Park JO, Jaskowiak NT, et al: Combined gene therapy and ionizing radiation is a novel treatment for human esophageal cancer. J Surg Oncol 9:500-504, 2002
18. Rasmussen HS, Rasmussen CS, Lempicki M, et al: TNFerade Biologic: Preclinical toxicology of a novel adenovector with a radiation-inducible promoter, carrying the human tumor necrosis factor alpha gene. Cancer Gene Ther 9:951-957, 2002
19. Nemunaitis J, Cunningham C, Buchanan A, et al: Intravenous infusion of a replication-selective adenovirus (ONYX-015) in cancer patients: Safety, feasibility and biological activity. Gene Ther 8:746-759, 2001
20. Brough DE, Lizonova A, Hsu C, et al: A gene transfer vector-cell line system for complete functional complementation of adenovirus early regions E1 and E4. J Virology 70:6497-6501, 1996
21. Herrlich P, Ponta H, Rahmsdorf H: DNA damaged-induced gene expression: Signal transduction and relation to growth factor signaling. Rev Physiol Biochem Pharmacol 119:187-223, 1992
22. Weichselbaum RR, Hallahan DE, Chen GTY: Biological and Physical Basis of Radiation Oncology, in Holland, JF et al (eds). Cancer Medicine, Lea and Febiger, Philadelphia, PA, 1993, pp 539-565
23. Holbrook N, Fornace A: Response to adversity: Molecular control of gene activation following genotoxic stress. New Biol 3:825-833, 1991
24. Dalla R, Rubin E, Sukhatme V, et al: Ionizing radiation activates transcription of the EGR1gene via CarG elements. Proc Natl Acad Sci U S A 89:10149-10153, 1992
25. Boothman D, Bouvard I, Hughes E: Identification and characterization of X-ray-induced proteins in human cells. Cancer Res 49:2871-2878, 1989
26. Hallahan DE, Beckett MA, Kufe D, et al: The interaction between human recombinant tumor necrosis factor and radiation in 13 human tumor cell lines. Int J Radiat Oncol Biol Phys 19:69-74, 1990
27. Sersa AG, Willingham V, Milas L: Antitumor effects of tumor necrosis factor alone or combined with radiotherapy. Int J Cancer 42: 129-134, 1988
28. Wong GH, McHugh T, Weber R, et al: Tumor necrosis factor selectively sensitizes human immunodeficiency virus-infected cells to heat and radiation. Proc Natl Acad Sci. USA 88:4372-4376, 1991
29. Baud V, Karin M: Signal transduction by tumor necrosis factor and its relatives. Trends Cell Biol 11:373-377, 2001
30. MacEwan DJ: TNF receptor subtype signaling: Differences and cellular consequences. Cell Signal 14:477-492, 2002
31. Laster SM, Wood JG, Gooding LR: Tumor necrosis factor can induce both apoptosis and necrotic forms of cell lysis. J Immunol 141:2629-2694, 1988
32. Mauceri HJ, Hanna NN, Wayne JD, et al: Tumor necrosis factor α (TNFα) gene therapy targeted by ionizing radiation selectively damages tumor vasculature. Cancer Res 56:4311-4314, 1996
33. Mauceri HJ, Seetharam S, Beckett MA, et al: Tumor production of angiostatin is enhanced after exposure to TNFα. Int J Cancer 97:410-415, 2002
34. Wiegmann K, Schutze S, Machleidt T, et al: Functional dichotomy of neutral and acidic sphingomyelinases in tumor necrosis factor signaling. Cell 78:1005-1015, 1994
35. Garcia-Barros M, Paris F, Cordon-Cardo C, et al: Tumor response to radiotherapy regulated by endothelial cell apoptosis. Science 300:1155-1159, 2003
36. Kianmanesh A. Hackett NR, Lee JM, et al: Intratumoral administration of low doses of an adenovirus vector encoding tumor necrosis factor α together with naïve dendritic cells elicits significant suppression of tumor growth without toxicity. Hum Gene Ther 12:2035, 2001
37. Khuri FR, Nemunaitis J, Ganly I, et al: A controlled trial of intratumoral ONYX-015, a selectively-replicating adenovirus in combination with cisplatin and 5-fluorouracil in patients with recurrent head and neck cancer. Nat Med 6:879-885, 2000
38. Vasey PA, Shulman LN, Campos S, et al: Phase I Trial of Intraperitoneal Injection of E1B-55-kd-Gene-Deleted Adenovirus ONYX-015 (d11520) given on Days 1 Through 5 every 3 weeks in patients with recurrent/refractory Epithelial Ovarian Cancer. J Clin Oncol 20:1562-1569, 2002
39. Mauceri HJ, Seung LP, Grdina WL, et al: Increased injection number enhances adenoviral genetic radiotherapy. Radiat Oncol Invest 5:220-226, 1997
40. Roldan GE, Gunderson LL, Nagorney DM, et al: External beam versus intraoperative and external beam irradiation for locally advanced pancreatic cancer. Cancer 61:1110-1117, 1988
41. Tepper J, Suit H: Radiation therapy alone for sarcoma of the soft tissue. Cancer 56:475-480, 1985
42. Slater J, McNeese M, Peters I: Radiation therapy for unresectable soft tissue sarcoma. Int J Radiat Oncol Biol Phys 12:1729-1735, 1986
43. Overgaard J, Overgaard M, Hansen PV, et al: Some factors of importance in the radiation treatment of malignant melanoma. Radiother Oncol 5:183-192, 1986
44. Mundt AJ, Nemunaitis J, Vijayakumar S, et al: TNFerade, an adenovector encoding the human tumor necrosis factor alpha gene, in soft tissue sarcoma in the extremity. Safety and early efficacy data. Eur J Cancer 38:3141, 2002 (suppl 7)
45. Creaven PJ, Plager JE, Dupere S: Phase I trial of recombinant human tumour necrosis factor. Cancer Chemother Pharmacol 20:137-144, 1987
46. Blick M, Sherwin SA Rosenblum M, et al: Phase I study of recombinant tumor necrosis factor in cancer patients. Cancer Res 47:2986-2989/1987