A phase II study of Hsp-7 (SGN-00101) in women with high-grade cervical intraepithelial neoplasia

Gynecologic Oncology

Volumn 106, Issue 3, 2007, Pages 558-566

  Roman, L D ^a   Wilczynski, S ^b   Muderspach, L I ^a   Burnett, A F ^a   O'Meara, A ^a   Brinkman, J A ^a   Kast, W M ^a   Facio, G ^a   Felix, J C ^a   Aldana, M ^a   Weber, J S ^a  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

Author keywords

Heat shock; Immune response; Papillomavirus; T cell; Vaccine

Indexed keywords

HEAT SHOCK PROTEIN 65; HEAT SHOCK PROTEIN 7; HYBRID PROTEIN; PROTEIN E7; SGN 00101; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CANCER DIAGNOSIS; CANCER GROWTH; CANCER IMMUNIZATION; CANCER REGRESSION; CLINICAL ARTICLE; CLINICAL TRIAL; COLPOSCOPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ELECTROSURGERY; FEMALE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; IMMUNE RESPONSE; INJECTION SITE REACTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; UTERINE CERVIX BIOPSY; UTERINE CERVIX CARCINOMA IN SITU;

ADULT; BACTERIAL PROTEINS; CANCER VACCINES; CD4-POSITIVE T-LYMPHOCYTES; CD8-POSITIVE T-LYMPHOCYTES; CERVICAL INTRAEPITHELIAL NEOPLASIA; CHAPERONINS; FEMALE; HUMANS; ONCOGENE PROTEINS, VIRAL; PAPILLOMAVIRUS INFECTIONS; PROSPECTIVE STUDIES; RECOMBINANT FUSION PROTEINS; UTERINE CERVICAL NEOPLASMS;

EID: 34548127036     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2007.05.038     Document Type: Article

References (55)

1. Koutsky L.A., Holmes K.K., Critchlow C.W., et al. A cohort study of the risk of cervical intraepithelial neoplasia grade II or III in relation to papillomavirus infection. N. Engl. J. Med. 327 (1992) 1272-1278
2. Munoz N., Bosch FX., de Sanjose S., et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N. Engl. J. Med. 348 (2003) 518-527
3. Koutsky L.A., Ault K.A., Wheeler C.M., et al. A controlled trial of a human papillomavirus type 16 vaccine. N. Engl. J. Med. 347 (2002) 1645-1651
4. Harper D.M., Franco E.L., Wheeler C., et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 364 (2004) 1757-1765
5. Villa L.L., Costa R.L., Petta CA., et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet 6 (2005) 271-278
6. Pecorelli S., Favalli G., Zigliani L., and Odicino F. Cancer in women. Int. J. Gynecol. Obstet. 82 (2002) 369-379
7. Sankaranarayanan R., Budukh A.M., and Rajkumar R. Effective screening programmes for cervical cancer in low- and middle-income developing countries. Bull. World Health Organ. 79 (2001) 954-962
8. Munger K., Werness B.A., Dyson N., et al. Complex formation of human papillomavirus E7 proteins with the retinoblastoma tumor suppressor gene product. EMBO J. 8 (1989) 4099-4105
9. Scheffner M., Werness B.A., Huibregste J.M., Levine A.J., and Howley P.M. The E6 oncoprotein encoded by human papillomavirus types 16 and 18 promotes degradation of p53. Cell 63 (1990) 1129-1136
10. Munger K., Phelps W.C., Bub V., et al. The E6 and E7 genes of the human papillomavirus type 16 together are necessary and sufficient for transformation of primary human keratinocytes. J. Virol. 63 (1989) 4417-4424
11. Crook T., Morganstern J.P., Crawford L., et al. Continued expression of HPV 16 E7 protein is required for maintenance of the transformed phenotype of cells co-transformed by HPV 16 plus EJ-ras. EMBO J. 8 (1989) 513-520
12. Kaufmann S.H. Heat shock proteins and the immune response. Immunol. Today 11 (1990) 129-136
13. Srivastava P.K. Therapeutic cancer vaccines. Curr. Opin. Immunol. 18 (2006) 2001-2005
14. Karlin S., Mrazek J., Ma J., and Brocchieri L. Predicted highly expressed genes in archaeal genomes. Proc. Natl. Acad. Sci. U. S. A. 102 (2005) 7303-7308
15. Udono H., and Srivastava P.K. Heat shock protein 70-associated peptides elicit specific cancer immunity. J. Exp. Med. 178 (1993) 1391-1396
16. Tamura Y., Peng P., Liu K., Daou M., and Srivastava P.K. Immunotherapy of tumors with autologous tumor-derived heat shock protein preparations. Science 278 (1997) 117-120
17. Suzue K., Zhou X., Eisen H.N., and Young R.A. Heat shock fusion proteins as vehicles for antigen delivery into the major histocompatibility complex class I presentation pathway. Proc. Natl. Acad. Sci. U.S.A. 94 (1997) 13146-13151
18. Janetzki S., Palla D., Rosenhauer V., Lochs H., Lewis J.J., and Srivastava P.K. Immunization of cancer patients with autologous cancer-derived heat shock protein gp96 preparations: a pilot study. Int. J. Cancer 88 (2000) 232-238
19. Belli F., Testori A., Rivoltini L., et al. Vaccination of metastatic melanoma patients with autologous tumor-derived heat shock protein gp96-peptide complexes: clinical and immunologic findings. Clin. Oncol. 20 (2002) 4169-4180
20. Mazzaferro V., Coppa J., Carrabba M.G., et al. Vaccination with autologous tumor-derived heat-shock protein gp96 after liver resection for metastatic colorectal cancer. Clin. Cancer Res. 9 (2003) 3235-3245
21. Wright T.C., Gagnon S., Richart R.M., and Ferenczy A. Treatment of cervical intraepithelial neoplasia using the loop electrosurgical excision procedure. Obstet. Gynecol. 79 (1992) 173-178
22. Hamid O., Solomon J., Scotland R., Garcia M., Sian S., Gee C., et al. Interleukin-12 augments immunity to a melanoma peptide vaccine which correlates with time to relapse in patients with resected high risk disease. Clin. Can. Res. 13 (2007) 215-222
23. Kadish A.S., Timmins P., Wang Y., Ho G.Y., Burk R.D., Ketz J., et al. Regression of cervical intraepithelial neoplasia and loss of human papillomavirus (HPV) infection is associated with cell -mediated immune responses to an HPV type 16 E7 peptide. Cancer Epidemiol. Biomark. Prev. 11 (2002) 483-488
24. Wong R., Lau R., Chang J., et al. Immune responses to a class II helper peptide epitope in patients with stage III/IV resected melanoma. Clin. Can. Res. 10 (2004) 5004-5013
25. Ting Y., and Manos M.M. Detection and typing of genital human papillomaviruses. In: Innis M., et al. (Ed). PCR protocols: a guide to methods and applications (1990), Academic Press, San Diego 356-367
26. Monk B.J., Cook N., Ahn C., Vasilev S.A., Berman M.L., and Wilczynski S.P. Comparison of the polymerase chain reaction and Southern blot analysis in detecting and typing human papilloma virus deoxyribonucleic acid in tumors of the lower female genital tract. Diagn. Mol. Pathol. 3 (1994) 283-291
27. Meyer T., Arndt R., Stockfleth E., Flammann H.T., and Wolf H. BioTechnology 19 (1995) 632-639
28. Wilczynski S.P., Oft M., Cook N., Liao S.Y., and Iftner T. Human papillomavirus type 6 in squamous cell carcinoma of the bladder and cervix. Human Pathol. 24 (1993) 96-102
29. Gravitt P.E., Peyton C.L., Alessi T.Q., et al. Improved amplification of genital human papillomaviruses. J. Clin. Microbiol. 38 (2000) 357-361
30. Simon R. Optimal two-stage designs for phase II clinical trials. Control. Clin. Trials 10 (1989) 1-10
31. Mao C., Koutsky L.A., Ault K.A., et al. Efficacy of human papilloma-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial. Obstet. Gynecol. 107 (2006) 18-27
32. Muderspach L., Wilczynski S., Roman L., et al. A phase I trial of a human papillomavirus (HPV) peptide vaccine for women with high-grade cervical and vulvar intraepithelial neoplasia who are HPV 16 positive. Clin. Cancer Res. 6 (2000) 3406-3416
33. Steller A., Gurski K.J., Murakami M., et al. Cell-mediated immunological responses in cervical and vaginal cancer patients immunized with a lipidated epitope of human papillomavirus type 16 E7. Clin. Cancer Res. 4 (1998) 2103-2109
34. Kaufmann A.M., Stern P.L., Rankin E.M., et al. Safety and immunogenicity of TA-HPV, a recombinant vaccinia virus expressing modified human papillomavirus (HPV)-16 and HPV-18 E6 and E7 genes, in women with progressive cervical cancer. Clin. Cancer Res. 8 (2002) 3676-3685
35. Baldwin P.J., van der Burg S.H., Boswell C.M., et al. Vaccinia-expressed human papillomavirus 16 and 18 E6 and E7 as a therapeutic vaccination for vulvar and vaginal intraepithelial neoplasia. Clin. Cancer Res. 9 (2003) 5205-5213
36. Davidson E.J., Faulkner R.L., Sehr P., et al. Effect of TA-CIN (HPV 16 L2E6E7) booster immunisation in vulval intraepithelial neoplasia patients previously vaccinated with TA-HPV (vaccinia virus encoding HPV 16/18 E6E7). Vaccine 22 (2004) 2722-2729
37. Smyth L.J., Van Poelgeest M.I., Davidson E.J., et al. Immunological responses in women with human papillomavirus type 16 (HPV-16)-associated anogenital intraepithelial neoplasia induced by heterologous prime-boost HPV-16 oncogene vaccination. Clin. Cancer Res. 10 (2004) 2954-2961
38. Corona Gutierrez C.M., Tinoco A., Navarro T., et al. Therapeutic vaccination with MVA E2 can eliminate precancerous lesions (CIN 1, CIN 2, and CIN 3) associated with infection by oncogenic human papillomavirus. Hum. Gene. Ther. 15 (2004) 421-431
39. Klencke B., Matijevic M., Urban R.G., et al. Encapsulated plasmid DNA treatment for human papillomavirus 16-associated anal cervical intraepithelial neoplasia: a Phase I study of ZYC101. Clin. Cancer Res. 8 (2002) 1028-1037
40. Sheets E.E., Urban R.G., Crum C.P., et al. Immunotherapy of human cervical high-grade cervical intraepithelial neoplasia with microparticle-delivered human papillomavirus 16 E7 plasmid DNA. Am. J. Obstet. Gynecol. 188 (2003) 916-926
41. Frazer I.H., Quinn M., Nicklin J.L., et al. Phase 1 study of HPV16-specific immunotherapy with E6E7 fusion protein and ISCOMATRIX adjuvant in women with cervical intraepithelial neoplasia. Vaccine 23 (2004) 172-181
42. Hallez S., Simon P., Maudoux F., et al. Phase I/II trial of immunogenicity of a human papillomavirus (HPV) type 16 E7 protein-based vaccine in women with oncogenic HPV-positive cervical intraepithelial neoplasia. Cancer Immunol. Immunother. 53 (2004) 642-650
43. Chu N.R., Wu H.B., Wu T., Boux L.J., Siegel M.I., and Mizzen L.A. Immunotherapy of a human papillomavirus (HPV) type 16 E7-expressing tumour by administration of fusion protein comprising Mycobacterium bovis Bacille Calmette-Guerin (BCG) hsp65 and HPV16 E7. Clin. Exp. Immunol. 121 (2000) 216-225
44. Neefe J.R., Chu N.R., and Mizzen L. CoVal fusions: a therapeutic vaccine platform using heat shock proteins to treat chronic viral infection and cancer. Dev. Biol. (Basel.) 116 (2004) 193-200
45. Einstein M.H., Kadish A.S., Burk R.D., et al. Heat shock protein (HSP)-based immunotherapy (HspE7) for treatment of CIN III (NCI 5850, NYGOG). Presented at the 36th Annual Meeting of the Society of Gynecologic Oncologists, Miami, Florida (March 2005)
46. Warrino D.E., Olson W.C., Knapp W.T., et al. Disease-stage variance in functional CD4(+) T-cell responses against novel pan-human leukocyte antigen-D region presented human papillomavirus-16 E7 epitopes. Clin. Cancer Res. 10 (2004) 3301-3308
47. van der Burg S.H., Ressing M.E., Kwappenberg K.M., et al. Natural T-helper immunity against human papillomavirus type 16 (HPV16) E7-derived peptide epitopes in patients with HPV16-positive cervical lesions: identification of 3 human leukocyte antigen class II-restricted epitopes. Int. J. Cancer 91 (2001) 612-618
48. + T cell immunity against early antigens E2 and E6. Cancer Res. 64 (2004) 5449-5455
49. Sarkar A.K., Tortolero-Luna G., Follen M., and Sastry K.J. Inverse correlation of cellular immune responses specific to synthetic peptides from the E6 and E7 oncoproteins of HPV-16 with recurrence of cervical intraepithelial neoplasia in a cross-sectional study. Gynecol. Oncol. 99 (2005) 251-261
50. Steele J.C., Mann C.H., Rookes S., et al. T-cell responses to human papillomavirus type 16 among women with different grades of cervical neoplasia. Br. J. Cancer 93 (2005) 248-259
51. Melnikow J., Nuovo J., Willan A.R., Chan B.K., and Howell L.P. Natural history of cervical squamous intraepithelial lesions: a meta-analysis. Obstet. Gynecol. 92 (1998) 727-735
52. Herrero R., Castle P.E., Schiffman M., et al. Epidemiologic profile of type-specific human papillomavirus infection and cervical neoplasia in Guanacaste, Costa Rica. JID 1911 (2005) 796-807
53. Pina-Sanchez P., Hernandez-Hernandez D.M., Lopez-Romero R., et al. Human papilloma virus-specific viral types are common in Mexican women affected by cervical lesions. Int. J. Gynecol. Cancer 16 (2006) 1041-1047
54. Kanodia S., Fahey L.M., and Kast W.M. Mechanisms used by human papillomavirus to escape the host immune response. Curr. Cancer Drug Targets 7 (2007) 79-89
55. Fausch S.C., Fahey L.M., Da Silva D.M., and Kast WM. Human papillomavirus can escape immune recognition through Langerhans cell phosphoinositide 3-kinase activation. J. Immunol. 174 (2005) 7172-7178