Ovarian cancer BRCA1 gene therapy: Phase I and II trial differences in immune response and vector stability

Clinical Cancer Research

Volumn 5, Issue 7, 1999, Pages 1708-1714

  Tait, David L ^a,c   Obermiller, Patrice S ^b   Hatmaker, Allison R ^b   Redlin Frazier, Sheryl ^a   Holt, Jeffrey T ^a,b  

^a VANDERBILT UNIVERSITY   (United States)

^b VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c EAST CAROLINA UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS VECTOR;

ADULT; AGED; ARTICLE; CANCER REGRESSION; CLINICAL ARTICLE; CLINICAL TRIAL; EXPRESSION VECTOR; GENE THERAPY; HUMAN; IMMUNE RESPONSE; ONCOGENE; OVARY CANCER; PRIORITY JOURNAL; RETROVIRUS;

ADOLESCENT; ADULT; AGED; ANIMALS; ANTIBODIES, VIRAL; BRCA1 PROTEIN; CLINICAL TRIALS, PHASE I; FEMALE; GENE THERAPY; GENETIC VECTORS; HUMANS; MICE; MICE, NUDE; MIDDLE AGED; OVARIAN NEOPLASMS; POLYMERASE CHAIN REACTION; RETROVIRIDAE;

EID: 0032790963     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (21)

1. Roth, J. A., Nguyen, D., Lawrence, D. D., Kemp, B. L., Carrasco, C. H., Ferson, D. Z., Hong, W. K., Komaki, R., Lee, J. J., Nesbitt, J. C., Pisters, K. M., Putnam, J. B., Schea, R., Shin, D. M., Walsh, G. L., Dolormente, M. M., Han, C. I., Martin, F. D., Yen, N., Xu, K., Stephens, L. C., McDonnell, T. J., Mukhopadhyay, T., and Cai, D. Retrovirus mediated wild-type p53 gene transfer to tumors of patients with lung cancer. Nat. Med., 2: 985-991, 1996.
2. Tait, D. L., Obermiller, P. S., Redlin-Frazier, S., Jensen, R. A., Welcsh, P., Dann, J., King, M. C., Johnson, D. H., and Holt, J. T. A Phase I trial of BRCA1sv gene therapy for ovarian cancer. Clin. Cancer Res., 3: 1959-1968, 1997.
3. Roth, J. A., and Cristiano, R. J. Gene therapy for cancer: what have we done and where are we going? J. Natl. Cancer Inst., 89: 21-39, 1997.
4. Kinzler, K. W., and Vogelstein, B. Gatekeepers and caretakers. Nature (Lond.), 386: 761-763, 1997.
5. Thompson, M. E., Jensen, R. A., Obermiller, P. S., Page, D. L., and Holt, J. T. Decreased expression of BRCA1 accelerates growth and is often present during sporadic breast cancer progression. Nat. Genet., 9: 444-450, 1995.
6. Mancini, D. N., Rodenhiser, D. I., Ainsworth, P. J., O'Malley, F. P., Singh, S. M., Xing, W., and T. K. Archer. CpG methylation within the 5′ regulatory region of the BRCA1 gene is tumor specific and includes a putative CREB binding site. Oncogene, 16: 1161-1169, 1998.
7. Holt, J. T., Thompson, M. E., Szabo, C., Robinson-Benion, C., Arteaga, C. L., King, M. C., and Jensen RA. Growth retardation and tumor inhibition by BRCA1. Nat. Genet., 12: 298-302, 1996.
8. Holt, J. T., Thompson, M. E., Szabo, C., Robinson-Benion, C., Arteaga, C. L., King, M. C., and Jensen RA. Growth retardation and tumor inhibition by BRCA1 (correction). Nat. Genet., 19: 102, 1998.
9. Editorial. No stranger to controversy. Nat. Genet., 17: 247-248, 1997.
10. Sotnasundaram, K., Zhang, H., Zeng, Y. X., Houvras, Y., Peng, Y., Zhang, H., Wu, G. S., Licht, J. D., Weber, B. L., and El-Deiry, W. S. Arrest of the cell cycle by the tumour-suppressor BRCA1 requires the CDK-inhibitor p21WAF1/CiP1. Nature (Lond.), 389: 187-190, 1997.
11. Zhang, H., Somasundaram, K., Peng, Y., Tian, H., Zhang, H., Bi, D., Weber, B. L., and El-Deiry, W. S. BRCA1 physically associates with p53 and stimulates its transcriptional activity. Oncogene, 16: 1713-1721, 1998.
12. Shao, N., Chai, Y. L., Shyam, E., Reddy, P., and Rao, V. N. Induction of apoptosis by the tumor suppressor protein BRCA1. Oncogene, 13: 1-7, 1996.
13. Jensen, D. E., Proctor, M., Marquis, S. T., Gardner, H. P., Ha, S. I., Chodosh, L. A., Ishov, A. M., Tommerup, N., Vissing, H., Sekido, Y., Minna, J., Borodovsky, A., Schultz, D. C., Wilkinson, K. D., Maul, G. G., Barlev, N., Berger, S. L., Prendergast, G. C., and Rauscher, F. J. 3rd. BAPI: a novel ubiquitin hydrolase which binds to the BRCA1 RING finger and enhances BRCA1-mediated cell growth suppression. Oncogene, 16: 1097-1112, 1998.
14. Humphrey, J. S., Salim, A., Erdos, M. R., Collins, F. S., Brody, L. C., and Klausner, R. D. Human BRCA1 inhibits growth in yeast: potential use in diagnostic testing. Proc. Natl. Acad. Sci. USA, 94: 5820-5825, 1997.
15. Burke, T. F., Cocke, K. S., Lemke, S. J., Angleton, E., Becker, G. W., and Beckmann, R. P. Identification of a BRCA1-associated kinase with potential biological relevance. Oncogene, 16: 1031-1040, 1998.
16. Simon, R. How large should a Phase II trial of a new drug be? Cancer Treat. Rep., 71: 1079-1085, 1987.
17. Pollock, R. E., and Roth, J. A. Cancer-induced immunosuppression: implications for therapy? Semin. Surg. Oncol., 5: 414-419, 1989.
18. Fletcher, J. P., Little, J. M., and Walker, P. J. Anergy and the severely ill surgical patient. Aust. NZ J. Surg., 56: 117-120, 1986.
19. Chwals, W. J., and Blackburn, G. L. Perioperative nutritional support in the cancer patient. Surg. Clin. North Am., 66: 1137-1165, 1986.
20. Parker, D., Bradley, C., Bogle, S. M., Lay, J., Masood, M., Hancock, A. K., Naylor, B., and Price, J. J. Serum albumin and CA125 are powerful predictors of survival in epithelial ovarian cancer. Br. J. Obstet. Gynecol., 101: 888-893, 1994.
21. Rollins, S. A., Birks, C. W., Setter, E., Squinto, S. P., and Rother, R. P. Retroviral vector producer cell killing in human serum by natural antibody and complement: strategies for evading the humoral immune response. Hum. Gene Ther., 7: 619-626, 1996.