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Title: A phase 2, single-arm study of an autologous dendritic cell treatment against mucin 1 in patients with advanced epithelial ovarian cancer.
Austin Authors: Mitchell, Paul L R ;Quinn, Michael A;Grant, Peter;Allen, David G;Jobling, Thomas W;White, Shane C;Zhao, Anne;Karanikas, Vaios;Vaughan, Hilary A;Pietersz, Geoffrey A;McKenzie, Ian F C;Gargosky, Sharron E;Loveland, Bruce E
Affiliation: Monash Medical Centre, Clayton Road, Clayton, VIC 3168, Australia
Mercy Hospital for Women, 163 Studley Road, Heidelberg, VIC 3084, Australia
University of Melbourne, Parkville, VIC 3052, Australia
Burnet Institute, 85 Commercial Road, Melbourne, VIC 3004, Australia
Monash University, Wellington Road, Clayton, VIC 3168, Australia
Prima BioMed, Ltd., 151 Macquarie Street, Sydney, NSW 2001, Australia
Royal Womens Hospital, 20 Flemington Road, Parkville, VIC 3052, Australia
University of Melbourne, Parkville, VIC 3052, Australia
Olivia Newton-John Cancer Wellness and Research Centre, Austin Health, Heidelberg, Victoria, Australia
Roche Innovation Center Zurich, 8952 Schlieren, Switzerland
Department of Medical Oncology, Austin Health, Heidelberg, Victoria, Australia
Issue Date: 18-Jun-2014
Publication information: Journal For Immunotherapy of Cancer 2014; 2: 16
Abstract: Mucin 1 antigen, highly expressed by epithelial ovarian cancer (EOC), is a potential target for immunotherapy. A previous successful phase 1 trial was conducted in patients with adenocarcinoma who were injected with Cvac, autologous monocyte-derived dendritic cells (DCs) incubated with mannosylated mucin 1 protein (M-FP). The present study was a phase 2 trial of Cvac in patients with advanced EOC.Eligible patients had EOC with progressive disease, defined as an increase in CA125 of ≥ 25% in 1 month. The primary endpoint was CA125 response or stabilization. Peripheral blood mononuclear cells were collected by leukapheresis and cultured to generate DCs. The DC were incubated with M-FP, and after washing were prepared for injection into the patient intradermally every 4 weeks for 3 doses, then every 10 weeks for up to 12 months.All 28 patients recruited were evaluable for safety and 26 for efficacy. All had undergone surgery and platinum-based chemotherapy, and 57% of patients received ≥ 3 chemotherapy regimens. There were no Grade 3 or 4 toxicities considered related to Cvac. Four patients showed CA125 response or stabilization (2 patients with major responses, 1 minor response, 1 stabilization) of median duration 10.3 months (5.3-16.3 months). An additional patient had > 25% CA125 reduction (not confirmed).Cvac immunotherapy was well tolerated. Clinical activity in EOC was evident based on decline or stabilization of CA125 in some patients, supporting ongoing development of Cvac in ovarian carcinoma and planning of additional trials of patients in remission is currently underway.
Gov't Doc #: 24995129
DOI: 10.1186/2051-1426-2-16
Type: Journal Article
Subjects: CA125
Ovarian cancer
Appears in Collections:Journal articles

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