Five-year follow-up of trial of replication-competent adenovirus-mediated suicide gene therapy for treatment of prostate cancer

Molecular Therapy

Volumn 15, Issue 3, 2007, Pages 636-642

  Freytag, Svend O ^a   Stricker, Hans ^a   Peabody, James ^a   Pegg, Jan ^a   Paielli, Dell ^a   Movsas, Benjamin ^a   Barton, Kenneth N ^a   Brown, Stephen L ^a   Lu, Mei ^a   Kim, Jae Ho ^a  

^a HENRY FORD HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANDROGEN; FLUCYTOSINE; GANCICLOVIR; ONCOLYTIC VIRUS; PROSTATE SPECIFIC ANTIGEN;

ADENOVIRUS; ADULT; AGED; ARTICLE; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER RELAPSE; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOTOXICITY; FOLLOW UP; HUMAN; MALE; MEDICAL DECISION MAKING; MORBIDITY; ONCOLYTIC VIROTHERAPY; PATIENT SELECTION; PROGNOSIS; PROSTATE CANCER; SALVAGE THERAPY; SUICIDE GENE THERAPY; THERAPY DELAY; TREATMENT INDICATION; TREATMENT OUTCOME; TUMOR GROWTH; VIRUS REPLICATION;

ADENOVIRIDAE; AGED; AGED, 80 AND OVER; ARYL HYDROCARBON HYDROXYLASES; FOLLOW-UP STUDIES; GENE THERAPY; GENES, TRANSGENIC, SUICIDE; HUMANS; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; STEROID HYDROXYLASES; TIME FACTORS; VIRUS REPLICATION;

ADENOVIRIDAE; HUMAN ADENOVIRUS;

EID: 33847212832     PISSN: 15250016     EISSN: 15250024     Source Type: Journal    
DOI: 10.1038/sj.mt.6300068     Document Type: Article

References (47)

1. American Cancer Society (2005). Cancer facts and figures 2005. American Cancer Society: Atlanta.
2. D'Amico, AV, Whittington, R, Malkowicz, SB, Schultz, D, Blank, K and Broderick, GA et al. (1998). Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA 280: 969-974.
3. Shipley, WU, Thames, HD, Sandler, HM, Hands, GE, Zietman, AL and Perez, CA et al. (1999). Radiation therapy for clinically localized prostate cancer. JAMA 281: 1598-1604.
4. Walsh, P, DeWeese, T and Eisenberger, M (2001). A structured debate: immediate versus deferred androgen suppression in prostate cancer - evidence for deferred treatment. J Urol 166: 508-516.
5. Holzbeierlein, J, Castle, E and Thrasher, J (2004). Complications of androgen deprivation therapy: Prevention and treatment. Oncology 18: 303-309.
6. Freytag, S, Rogulski, K, Paielli, D, Gilbert, J and Kim, JH (1998). A novel three-pronged approach to selectively kill cancer cells: concomitant viral, double suicide gene, and radiotherapy. Hum Gene Ther 9: 1323-1333.
7. Rogulski, KR, Wing, MS, Paielli, DL, Gilbert, JD, Kim, JH and Freytag, SO (2000). Double suicide gene therapy augments the therapeutic efficacy of a replication-competent lytic adenovirus through enhanced cytotoxicity and radiosensitization. Hum Gene Ther 11: 67-76.
8. Freytag, SO, Paielli, D, Wing, M, Rogulski, K, Brown, S and Kolozsvary, A et al. (2002). Efficacy and toxicity of replication-competent adenovirus-mediated double suicide gene therapy in combination with radiation therapy in an orthotopic mouse prostate cancer model. Int J Radiat Oncol Biol Phys 54: 873-886.
9. Barton, KN, Paielli, D, Zhang, Y, Koul, S, Brown, SL and Lu, M et al. (2006). Second-generation replication-competent oncolytic adenovirus armed with improved suicide genes and the ADP gene demonstrate greater efficacy without increased toxicity. Mol Ther 13: 347-356.
10. Freytag, SO, Khil, M, Stricker, H, Peabody, J, Menon, M and DePeralta-Venturina, et al. (2002). Phase I study of replication-competent adenovirus-mediated double suicide gene therapy for the treatment of locally recurrent prostate cancer. Cancer Res 62: 4968-4976.
11. Freytag, SO, Stricker, H, Pegg, J, Paielli, D, Pradhan, DG and Peabody, J et al. (2003). Phase I study of replication-competent adenovirus-mediated double suicide gene therapy in combination with conventional-dose three-dimensional conformal radiation therapy for the treatment of newly diagnosed, intermediate- to high-risk prostate cancer. Cancer Res 63: 7497-7506.
12. Herman, JR, Adler, HL, Aguilar-Cordova, E, Rojas-Martinez, A, Woo, S and Timme, TL et al. (1999). In situ gene therapy for adenocarcinoma of the prostate: A phase I clinical trial. Hum Gene Ther 10: 1239-1249.
13. Teh, BS, Aguilar-Cordova, E, Kernen, K, Chou, CC, Shaley, M and Vlachaki, MT et al. (2001). Phase I/II trial evaluating combined radiotherapy and in situ gene therapy with or without hormonal therapy in the treatment of prostate cancer - a preliminary report. Int J Radiat Oncol Biol Phys 51: 605-613.
14. DeWeese, TL, van der Poel, H, Li, S, Mikhak, B, Drew, R and Goermann, M et al. (2001). A Phase I trial of CV706, a replication-competent PSAselective oncolytic adenovirus, for the treatment of locally recurrent prostate cancer following radiation therapy. Cancer Res 61: 7464-7472.
15. Kubo, H, Gardner, T, Wada, Y, Koeneman, K and Gotoh, G (2003). Phase I dose escalation clinical trial of adenovirus vector carrying osteocalcin promoter-driven herpes simplex virus thymidine kinase in localized and metastatic hormone-refractory prostate cancer. Hum Gene Ther 14: 227-241.
16. Teh, BS, Ayala, G, Aguilar, L, Mai, WY, Timme, TL and Vlachaki, MT et al. (2004). Phase I-II trial evaluating combined intensity-modulated radiotherapy and in situ gene therapy with or without hormonal therapy in treatment of prostate cancer-interim report on PSA response and biopsy data. Int J Radiat Oncol Biol Phys 58: 1520-1529.
17. Small, EJ, Carducci, MA, Burke, JM, Rodriguez, R, Fong, L and van Ummersen, L et al. (2006). A phase I trial of intravenous CG7870, a replication-selective, prostate-specific antigen-targeted oncolytic adenovirus, for the treatment of hormone-refractory, metastatic prostate cancer. Mol Ther 14: 107-117.
18. Pollack, A, Zagars, G and Kavadi, V (1994). Prostate specific antigen doubling time and disease relapse after radiotherapy for prostate cancer. Cancer 74: 670-678.
19. Zagars, G and Pollack, A (1997). Kinetics of serum prostate-specific antigen after external beam radiation for clinically localized prostate cancer. Radiother Oncol 44: 213-221.
20. Sartor, CI, Strawderman, MH, Lin, ZH, Kish, KE, McLaughlin, PW and Sandler, HM (1997). Rate of PSA rise predicts metastatic versus local recurrence after definitive radiotherapy. Int J Radiat Oncol Biol Phys 38: 941-947.
21. Sandler, HM, Dunn, RL, McLaughlin, PW, Hayman, JA, Sullivan, MA and Taylor, JM (2000). Overall survival after prostate-specific-antigen-detected recurrence following conformal radiation therapy. Int J Radiat Oncol Biol Phys 48: 629-633.
22. D'Amico, AV, Cote, L, Loffredo, M, Renshaw, AA and Schultz, D (2002). Determinants of prostate cancer-specific survival following radiation therapy for patients with clinically localized prostate cancer. J Clin Oncol 20: 4567-4573.
23. D'Amico, AV, Moul, JW, Carroll, PR, Sun, L, Lubeck, D and Chen, MH (2003). Surrogate end point for prostate cancer-specific mortality following radical prostatectomy or radiation therapy. J Natl Cancer Inst 95: 1376-1383.
24. D'Amico, AV, Chen, MH, Roehl, KA and Catalona, WJ et al. (2004). Preoperative PSA velocity and the risk of death from prostate cancer after radical prostatectomy. N Engl J Med 351: 125-135.
25. Lee, AK, Levy, LB, Cheung, R and Kuban, D (2005). Prostate-specific antigen doubling time predicts clinical outcome and survival in prostate cancer patients treated with combined radiation and hormone therapy. Int J Radiat Oncol Biol Phys 63: 456-462.
26. Patel, DA, Presti, JC, McNeal, JE, Gill, H, Brooks, JD and King, CR (2005). Preoperative PSA velocity is an independent prognostic factor for relapse after radical prostatectomy. J Clin Oncol 23: 6157-6162.
27. Freedland, SJ, Humphreys, EB, Mangold, LA, Eisenberger, M, Dorey, FJ and Walsh, PC et al. (2005). Risk of prostate cancer-specific mortality following biochemical recurrence after radical prostatectomy. JAMA 294: 433-439.
28. D'Amico, AV, Kantoff, P, Loffredo, M, Renshaw, AA, Loffredo, B and Chen, MH (2006). Predictors of mortality after prostate-specific antigen failure. Int J Radiat Oncol Biol Phys 65: 656-660.
29. Pound, CR, Partin, AW, Eisenberger, MA, Chan, DW, Pearson, JD and Walsh, PC (1999). Natural history of progression after PSA elevation following radical prostatectomy. JAMA 281: 1642-1645.
30. Caruso, M, Panis, Y, Gagandeep, S, Houssin, D, Salzmann, JL and Klatzmann, D (1993). Regression of established macroscopic liver metastases after in situ transduction of a suicide gene. Proc Natl Acad Sci 90: 7024-7028.
31. Mullen, R, Coale, M and Blaese, R (1994). Tumors expressing the cytosine deaminase suicide gene can be eliminated in vivo with 5-fluorocytosine and induce protective immunity to wild-type tumor. Cancer Res 54: 1503-1506.
32. Barba, D, Hardin, J, Sadelain, M and Gage, F (1994). Development of anti-tumor immunity following thymidine kinase-mediated killing of experimental brain tumors. Proc Natl Acad Sci USA 91: 4348-4352.
33. Vile, R, Nelson, J, Casleden, S, Chong, H and Hart, I (1994). Systemic gene therapy of murine melanoma using tissue specific expression of the HSVtk gene involves an immune component. Cancer Res 54: 6228-6234.
34. Consalvo, M, Mullen, CA, Modesti, A, Musiani, P, Allione, A and Cavallo, F et al. (1995). 5-fluorocytosine-induced eradication of murine adenocarcinomas engineered to express the cytosine deaminase suicide gene requires host immune competence and leaves an efficient memory. J Immun 154: 5302-5312.
35. Vile, RG, Castleden, S, Marshall, J, Camplejohn, R, Upton, C and Chong, H (1997). Generation of an anti-tumor immune response in a non-immunogenic tumor: HSVtk-killing in vivo stimulates a mononuclear cell infiltrate and a Th1-like profile of intratumoral cytokine expression. Int J Cancer 71: 267-274.
36. Melcher, A, Todryk, S, Hardwick, N, Ford, M, Jacobson, M and Vile, RG (1998). Tumor immunogenicity is determined by the mechanism of cell death via induction of heat shock protein expression. Nat Med 4: 581-587.
37. Singer, PA, Tasch, ES, Stocking, C, Rubin, S, Siegler, M and Weichselbaum, R (1991). Sex or survival: Trade-offs between quality and quantity of life. J Clin Oncol 9: 328-334.
38. Bastacky, S, Walsh, P and Epstein, J (1991). Needle biopsy associated tumor tracking of adenocarcinoma of the prostate. J Urol 145: 1003-1007.
39. Whyte, P, Buchkovich, KF, Horowitz, JM, Friend, SH, Raybuck, M and Weinberg, RA et al. (1998). Association between an oncogene and an anti-oncogene: The adenovirus E1A proteins bind to the retinoblastoma gene product. Nature 334: 124-129.
40. Yew, P and Berk, A (1992). Inhibition of p53 transactivation required for transformation by adenovirus early 1B protein. Nature 357: 82-85.
41. Moore, M, Horikoshi, N and Shenk, T (1996). Oncogenic potential of the adenovirus E4orf6 protein. Proc Natl Acad Sci USA 93: 11295-11301.
42. McAllister, R, Gilden, R and Green, M (1972). Adenoviruses in human cancer. Lancet 1: 831-833.
43. Green, M, Wold, W, Mackey, J and Rigden, P (1979). Analysis of human tonsil and cancer DNAs and RNAs for DNA sequences of group C (serotypes 1, 2, 5, and 6) human adenoviruses. Proc Natl Acad Sci USA 76: 6606-6610.
44. D'Amico, A and Hanks, G (1993). Linear regressive analysis using prostate-specific antigen doubling time for predicting tumor biology and clinical outcome in prostate cancer. Cancer 72: 2638-2643.
45. Cox, J, Kaplan, R and for the American Society for Therapeutic Radiology and Oncology Consensus Panel (1997). Consensus statement: Guidelines for PSA following radiation therapy. Int J Radiat Oncol Biol Phys 37: 1035-1041.
46. Buyyounouski, MK, Hanlon, AL, Eisenberg, DF, Horwitz, EM, Feigenberg, SJ and Uzzo, RG et al. (2005). Defining biochemical failure after radiotherapy with and without androgen deprivation for prostate cancer. Int J Radiat Oncol Biol Phys 63: 1455-1462.
47. Manly, B (1997). Randomization, bootstrap and Monte Carlo methods in biology, 2nd edn, Chapman & Hall: London.