A phase I clinical trial of an adenovirus-mediated endostatin gene (E10A) in patients with solid tumors

Cancer Biology and Therapy

Volumn 6, Issue 5, 2007, Pages 648-653

  Lin, Xubin ^a   Huang, Huiqiang ^a   Li, Su ^a   Li, Hongli ^a   Li, Yuhong ^a   Cao, Ye ^a   Zhang, Dongsheng ^a   Xia, Yunfei ^a   Guo, Ying ^a   Huang, Wenlin ^a   Jiang, Wenqi ^a,b  

^a SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^b SUN YAT SEN UNIVERSITY   (China)

Author keywords

Adenovirus; Antiangiogenesis; Clinical trial; Endostatin; Gene therapy; Phase I; Tumor

Indexed keywords

ENDOSTATIN;

ADENOVIRUS; ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; FEMALE; HUMAN; HUMAN TISSUE; LIVER TOXICITY; MALE; NASOPHARYNX CARCINOMA; PATIENT ASSESSMENT; SOLID TUMOR; TUMOR BIOPSY; TUMOR NECROSIS; VIRUS SHEDDING;

EID: 34548277477     PISSN: 15384047     EISSN: 15558576     Source Type: Journal    
DOI: 10.4161/cbt.6.5.4004     Document Type: Article

References (29)

1. Bergers G, Benjamin LE. Tumorigenesis and the angiogenic switch. Nat Rev Cancer 2003; 3:401-10.
2. Folkman J, Klagsbrun M. Angiogenic factors. Science 1987; 235:442-7.
3. Folkman J. Antiangiogenesis in cancer therapy-endostatin and its mechanisms of action. Exp Cell Res 2006; 312:594-607.
4. O'Reilly MS, Boehm T, Shing Y, Fukai N, Vasios G, Lane WS, Flynn E, Birkhead JR, Oslen BR, Folkman J. Endostatin: An endogenous inhibitor of angiogenesis and tumor growth. Cell 1997; 88:277-85.
5. Kisker O, Becker CM, Prox D, Fannon M, D'Amato R, Flynn E, Fogler WE, Sim BK, Allred EN, Pirie-Shepherd SR, Folkman J. Continuous administration of endostatin by intraperitoneally implanted osmotic pump improves the efficacy and potency of therapy in a mouse xenograft tumor model. Cancer Res 2001; 61:7669-74.
6. Herbst RS, Hess KR, Tran HT, Tseng JE, Mullani NA, Charnsangavej C, Madden T, Davis DW, McConkey DJ, O'Reilly MS, Ellis LM, Pluda J, Hong WK, Abbruzzese JL. Phase I study of recombinant human endostatin in patients with advanced solid tumors. J Clin Oncol 2002; 20:3792-803.
7. Eder Jr JP, Supko JG, Clark JW, Puchalski TA, Garcia-Carbonero R, Ryan DP, Shulman LN, Proper J, Kirvan M, Rattner B, Connors S, Keogan MT, Janicek MJ, Fogler WE, Schnipper L, Kinchla N, Sidor C, Phillips E, Folkman J, Kufe DW. Phase I clinical trial of recombinant human endostatin administered as a short intravenous infusion repeated daily. J Clin Oncol 2002; 20:3772-84.
8. Thomas JP, Arzoomanian RZ, Alberti D, Marnocha R, Lee F, Friedl A, Tutsch K, Dresen A, Geiger P, Pluda J, Fogler W, Schiller JH, Wilding G. Phase I pharmacokinetic and pharmacodynamic study of recombinant human endostatin in patients with advanced solid tumors. J Clin Oncol 2003; 21:223-31.
9. Hansma AH, Broxterman HJ, van der Horst I, Yuana Y, Boven E, Giaccone G, Pinedo HM, Hoekman K. Recombinant human endostatin administered as a 28-day continuous intravenous infusion, followed by daily subcutaneous injections: A phase I and pharmacokinetic study in patients with advanced cancer. Annal Oncol 2005; 16:1695-701.
10. Wang JW, Sun Y, Liu YY, Yu QT, Zhang YP, Li K, Zhu YZH, Zhou Q, Hou M, Guan ZZ, Li WL, Zhuang W, Wang DL, Liang HJ, Qin FZ, Lu HS, Liu XQ, Sun H, Zhang YJ, Wang JJ, Luo SX, Yang RH, Tu YR, Wang XW, Song SP, Zhou JM, You LF, Wang J, Yao C. Results of randomized, multicenter, double-blind phase III trial of rh-endostatin (YH-16) in treatment of advanced nonsmall cell lung cancer patients. Chin J Lung Cancer 2005; 8:283-90.
11. Folkman J. Antiangiogenic gene therapy. Proc Natl Acad Sci USA 1998; 95:9064-6.
12. Yoon SS, Eto H, Lin CM, Nakamura H, Pawlik TM, Song SU, Tanabe KK. Mouse end-ostatin inhibits the formation of lung and liver metastases. Cancer Res 1999; 59:6251-6.
13. Oga M, Takenaga K, Sato Y, Nakajima H, Koshikawa N, Osato K, Sakiyama S. Inhibition of metastatic brain tumor growth by intramuscular administration of the endostatin gene. Int J Oncol 2003; 23:73-9.
14. Wu Y, Yang L, Hu B, Liu JY, Su JM, Luo Y, Ding ZY, Niu T, Li Q, Xie XJ, Wen YJ, Tian L, Kan B, Mao YQ, Wei YQ. Synergistic anti-tumor effect of recombinant human endostatin adenovirus combined with gemcitabine. Anti-cancer Drugs 2005; 16:551-7.
15. Luo X, Slater JM, Gridley DS. Enhancement of radiation effects by pXLG-mEndo in a lung carcinoma model. Int J Radiat Oncol Biol Phys 2005; 63:553-64.
16. Liang ZH, Wu PH, Li L, Xue G, Zeng YX, Huang WL. Inhibition of tumor growth in xenografted nude mice with adenovirus-mediated endostatin gene comparison with recombinant endostatin protein. Chin Med J 2004; 117:1809-14.
17. Li L, Huang JL, Liu QC, Wu PH, Liu RY, Zeng YX, Huang WL. Endostatin gene therapy for liver cancer by a recombinant adenovirus delivery. World J Gastroenterol 2004; 10:1867-71.
18. Reid T, Galanis E, Abbruzzese J, Sze D, Wein LM, Andrews J, Randlev B, Heise C, Uprichard M, Hatfield M, Rome L, Rubin J, Kirn D. Hepatic arterial infusion of a replication-selective oncolytic adenovirus (dl1520): Phase II Viral, immunologic, and clinical endpoints. Cancer Res 2002; 62:6070-9.
19. Ganly I, Kirn D, Eckhardt G, Rodriguez GI, Soutar DS, Otto R, Robertson AG, Park O, Gulley ML, Heise C, Von Hoff DD, Kaye SB. A Phase I study of onyx-015, an E1B attenuated adenovirus, administered intratumorally to patients with recurrent head and neck cancer. Clini Cancer Res 2000; 6:798-806.
20. Stewart AK, Lassam NJ, Quirt IC, Bailey DJ, Rotstein LE, Krajden M, Dessureault S, Gallinger S, Cappe D, Wan Y, Addison CL, Moen RC, Gauldie J, Graham FL. Adenovector-mediated gene delivery of interleukin-2 in metastatic breast cancer and melanoma: Results of a phase 1 clinical trial. Gene Ther 1999; 6:350-63.
21. Heise CC, Williams AM, Xue S, Propst M, Kirn DH. Intravenous administration of ONYX-015, a selectively-replicating adenovirus, induces antitumoral efficacy. Cancer Res 1999; 59:2623-8.
22. Tolcher AW, Hao D, de Bono J, Miller A, Patnaik A, Hammond LA, Smetzer L, Van Wart Hood J, Merritt J, Rowinsky EK, Takimoto C, Von Hoff D, Eckhardt SG. Phase I, pharmacokinetic, and pharmacodynamic study of intravenously administered Ad5CMV-p53, an adenoviral vector containing the wild-type p53 gene, in patients with advanced cancer. J Clin Oncol 2006; 24:2052-8.
23. Herman JR, Adler HL, Aguilar-Cordova E, Rojas-Martinez A, Woo S, Timme TL, Wheeler TM, Thompson TC, Scardino PT. In situ gene therapy for adenocarcinoma of the prostate: A phase I clinical trial. Hum Gene Ther 1999; 10:1239-49.
24. Griscelli F, Opolon P, Saulnier P, Mami-Chouaib F, Gautier E, Echchakir H, Angevin E, Le Chevalier T, Bataille V, Squiban P, Tursz T, Escudier B. Recombinant adenovirus shedding after intratumoral gene transfer in lung cancer patients. Gene Therapy 2003; 10:386-95.
25. Skovseth DK, Veuger MJ, Sorensen DR, De Angelis PM, Haraldsen G. Endostatin dramatically inhibits endothelial cell migration, vascular morphogenesis, and perivascular cell recruitment in vivo. Blood 2005; 105:1044-51.
26. He GA, Xue G, Xiao L, Wu JX, Xu BL, Huang JL, Liang ZH, Xiao X, Huang BJ, Liu RY, Huang W. Dynamic distribution and expression in vivo of human endostatin gene delivered by adenoviral vector. Life Sci 2005; 77:1331-40.
27. Sund M, Hamano Y, Sugimoto H, Sudhakar A, Soubasakos M, Yerramalla U, Benjamin LE, Lawler J, Kieran M, Shah A, Kalluri R. Function of endogenous inhibitors of angiogenesis as endothelium specific tumor suppressors. Proc Natl Acad. Sci USA 2005; 102:2934-9.
28. Zorick TS, Mustacchi Z, Bando SY, Zatz M, Moreira-Filho CA, Olsen B, Passos-Bueno MR. High serum endostatin levels in Down syndrome: Implications for improved treatment and prevention of solid tumours. Eur J Hum Genet 2001; 9:811-4.
29. Yang L, Wang JW, Tang ZM, Liu XW, Huang J, Li ST, Dong Y, Zhang HP, Xue L, Chu DT, Sun Y. A phase I clinical trial for recombinant human endostatin. Chin J New Drugs 2004; 13:548-53.