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

Molecular Therapy - Tập 14 - Trang 107-117 - 2006
Eric J. Small1, Michael A. Carducci2, James M. Burke3, Ron Rodriguez2, Lawrence Fong1, Lynn van Ummersen4, D.C. Yu3, Junko Aimi3, Dale Ando3, Peter Working3, David Kirn5, George Wilding4
1University of California, Comprehensive Cancer Center San Francisco, San Francisco, CA 94143, USA
2Prostate Cancer Program at the Kimmel Cancer Center at Johns Hopkins, Baltimore, MD 21231, USA
3Cell Genesys, Inc., Division of Clinical Research, South San Francisco, CA 94080, USA
4Department of Medical Oncology, University of Wisconsin, WI 53705, USA
5Department of Pharmacology, Oxford University, OX2 6DP Oxford, UK

Tài liệu tham khảo

Kirn, 2001, Replication-selective virotherapy for cancer: biological principles, risk management and future directions, Nat Med., 7, 781, 10.1038/89901 Kirn, 2000, Replication-selective oncolytic adenoviruses: virotherapy aimed at genetic targets in cancer, Oncogene, 19, 6660, 10.1038/sj.onc.1204094 Heise, 2000, An adenovirus E1A mutant that demonstrates potent and selective antitumoral efficacy, Nat. Med., 6, 1134, 10.1038/80474 Heise, 1997, ONYX-015, an E1B gene-attenuated adenovirus, causes tumor-specific cytolysis and antitumoral efficacy that can be augmented by standard chemotherapeutic agents, Nat. Med., 3, 639, 10.1038/nm0697-639 DeWeese, 2001, A phase I trial of CV706, a replication-competent, PSA selective oncolytic adenovirus, for the treatment of locally recurrent prostate cancer following radiation therapy, Cancer Res., 61, 7464 Yu, 1999, The addition of adenovirus region E3 enables calydon virus 787 to eliminate distant prostate tumor xenografts, Cancer Res., 59, 4200 Zhang, 2002, Identification of human uroplakin II promoter and its use in the construction of CG8840, a urothelium-specific adenovirus variant that eliminates established bladder tumors in combination with docetaxel, Cancer Res., 62, 3743 Kirn, 2001, Clinical research results with dl1520 (Onyx-015), a replication-selective adenovirus for the treatment of cancer: what have we learned?, Gene Ther., 8, 89, 10.1038/sj.gt.3301377 Nemunaitis, 2000, Selective replication and oncolysis in p53 mutant tumors with Onyx-015, an E1B-55kD gene-deleted adenovirus, in patients with advanced head and neck cancer: a phase II trial, Cancer Res., 60, 6359 Khuri, 2000, 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, 10.1038/78638 Vasey, 2002, Phase I trial of intraperitoneal injection of the E1B-55kD-deleted adenovirus ONYX-015 adenovirus in patients with recurrent/refractory epithelial ovarian cancer, J. Clin. Oncol., 20, 1562, 10.1200/JCO.20.6.1562 Reid, 2001, Intra-arterial administration of a replication-selective adenovirus (dl1520) in patients with colorectal carcinoma metastatic to the liver: a phase I trial, Gene Ther., 8, 1618, 10.1038/sj.gt.3301512 Reid, 2002, Hepatic arterial infusion of a replication-selective oncolytic adenovirus (dl1520): phase II viral, immunologic, and clinical endpoints, Cancer Res., 62, 6070 Nemunaitis, 2002, Intravenous infusion of a replication-selective adenovirus (ONYX-015) in cancer patients: safety, feasibility and biological activity, Gene Ther., 8, 746, 10.1038/sj.gt.3301424 Hamid, 2003, Phase II trial of intravenous CI-1042 in patients with metastatic colorectal cancer, J. Clin. Oncol., 21, 1498, 10.1200/JCO.2003.09.114 Reid, 2002, Intravascular adenoviral agents in cancer patients: lessons from clinical trials, Cancer Gene Ther., 9, 979, 10.1038/sj.cgt.7700539 Tannock, 1996, Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points, J. Clin. Oncol., 14, 1756, 10.1200/JCO.1996.14.6.1756 Freytag, 1998, A novel three-pronged approach to kill cancer cells selectively: concomitant viral, double suicide gene, and radiotherapy, Hum. Gene Ther., 9, 1323, 10.1089/hum.1998.9.9-1323 Freytag, 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 Nemunaitis, 2001, Intravenous infusion of a replication-selective adenovirus (ONYX-015) in cancer patients: safety, feasibility and biological activity, Gene Ther., 8, 746, 10.1038/sj.gt.3301424 Nemunaitis, 2000, Adenovirus-mediated p53 gene transfer in sequence with cisplatin to tumors of patients with non-small-cell lung cancer, J. Clin. Oncol., 18, 609, 10.1200/JCO.2000.18.3.609 Senzer, 2004, TNFerade biologic, an adenovector with a radiation-inducible promoter controlling expression of TNF-alpha, J. Clin. Oncol., 22, 592, 10.1200/JCO.2004.01.227 Wein, 2003, Validation and analysis of a mathematical model of a replication-competent oncolytic virus for cancer treatment: implications for virus design and delivery, Cancer Res., 63, 1317 Reid, 1999, A phase I/II trial of ONYX-015 administered by hepatic artery infusion to patients with colorectal carcinoma Rosenberg, 2003, Prostate cancer update, Curr. Opin. Oncol., 15, 217, 10.1097/00001622-200305000-00007 Blasberg, 2003, Molecular-genetic imaging: current and future perspectives, J. Clin. Invest., 111, 1620, 10.1172/JCI18855 Mistchenko, 1994, Cytokines in adenoviral disease in children: association of interleukin-6, interleukin-8, and tumor necrosis factor alpha levels with clinical outcome, J. Pediatr., 124, 714, 10.1016/S0022-3476(05)81360-5 Selby, 1987, Tumor necrosis factor in man: clinical and biological observations, Br J Cancer, 56, 803, 10.1038/bjc.1987.294 Raper, 2003, Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer, Mol. Genet. Metab., 80, 148, 10.1016/j.ymgme.2003.08.016 Raper, 2002, A pilot study of in vivo liver-directed gene transfer with an adenoviral vector in partial ornithine transcarbamylase deficiency, Hum. Gene Ther., 13, 163, 10.1089/10430340152712719 Heise, 2000, Replication-selective adenoviruses as oncolytic agents, J. Clin. Invest., 105, 847, 10.1172/JCI9762 Tomko, 1997, HCAR and MCAR: the human and mouse cellular receptors for subgroup C adenoviruses and group B coxsackieviruses, Proc. Natl. Acad. Sci. USA, 94, 3352, 10.1073/pnas.94.7.3352 Yu, 2001, Antitumor synergy of CN787, a prostate cancer-specific adenovirus, and paclitaxel and docetaxel, Cancer Res., 61, 517 Small, 2001, Docetaxel in prostate cancer, Anticancer Drugs, 12, S17 Akiyama, 2004, Ablating CAR and integrin binding in adenovirus vectors reduces nontarget organ transduction and permits sustained bloodstream persistence following intraperitoneal administration, Mol. Ther., 9, 218, 10.1016/j.ymthe.2003.10.010 Suzuki, 2001, A conditionally replicative adenovirus with enhanced infectivity shows improved oncolytic potency, Clin. Cancer Res., 7, 120 Fisher, 2001, Polymer-coated adenovirus permits efficient retargeting and evades neutralizing antibodies, Gene Ther., 8, 341, 10.1038/sj.gt.3301389 Tannock, 2004, Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer, N. Engl. J. Med., 351, 1502, 10.1056/NEJMoa040720 Petrylak, 2004, Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer, N. Engl. J. Med., 351, 1513, 10.1056/NEJMoa041318 Yu, 1999, Identification of the transcriptional regulatory sequences of human kallikrein 2 and their use in the construction of calydon virus 764, an attenuated replication competent adenovirus for prostate cancer therapy, Cancer Res., 59, 1498 Chen, 2000, Pre-existent adenovirus antibody inhibits systemic toxicity and antitumor activity of CN706 in the nude mouse LNCaP xenograft model: implications and proposals for human therapy, Hum. Gene Ther., 11, 1553, 10.1089/10430340050083289