Chemoablation of cutaneous and subcutaneous metastatic melanoma using PV-1

Thompson, J. F., Hersey, P., Smithers, B. M., Coventry, B., Ross, M. I. and Wachter, E. A. (2008). Chemoablation of cutaneous and subcutaneous metastatic melanoma using PV-1. In: Asia-Pacific Journal of Clinical Oncology.. Clinical Oncological Society of Australia and the International Association of Cancer Registries Joint Scientific Meeting, held in conjunction with the Australian and New Zealand Gastro-Oesophageal Surgery Association, Sydney, Australia, (A72-A72). 18–20 November 2008. doi:10.1111/j.1743-7563.2008.00201_1.x


Author Thompson, J. F.
Hersey, P.
Smithers, B. M.
Coventry, B.
Ross, M. I.
Wachter, E. A.
Title of paper Chemoablation of cutaneous and subcutaneous metastatic melanoma using PV-1
Conference name Clinical Oncological Society of Australia and the International Association of Cancer Registries Joint Scientific Meeting, held in conjunction with the Australian and New Zealand Gastro-Oesophageal Surgery Association
Conference location Sydney, Australia
Conference dates 18–20 November 2008
Proceedings title Asia-Pacific Journal of Clinical Oncology.   Check publisher's open access policy
Place of Publication Asia
Publisher Blackwell Publishing
Publication Year 2008
Sub-type Oral presentation
DOI 10.1111/j.1743-7563.2008.00201_1.x
ISSN 1743-7555
Volume 4
Issue s2
Start page A72
End page A72
Total pages 1
Language eng
Abstract/Summary PV-10 is a sterile solution of rose bengal being studied as an ablative agent for solid tumors. Upon intralesional administration, it may elicit both local chemoablation and an immune-mediated bystander response. Data from a phase 1 study in 20 subjects with cutaneous and/or subcutaneous AJCC Stage III or IV metastatic melanoma will be presented. Subjects received a single treatment of 1–20 lesions; an additional 1–3 untreated lesions were observed for bystander effects. The maximum dose per subject was 15 mL PV-10, mean dose 2.7 mL. A total of 110 treated lesions and 40 bystander lesions were evaluable 12 to 24 weeks after treatment. PV-10 was well tolerated, with a single serious adverse event, a Grade 3 photosensitivity that resolved spontaneously without long-term sequela. The most common adverse events were transient mild to moderate pain at the treatment site in 75% of subjects, followed by local inflammation or mild infection in 25% of subjects. The effects of PV-10 were largely confined to the injected tumors, typically characterised by necrosis of injected lesions within 1–7 days, followed by gradual involution over several weeks. Forty percent of subjects achieved an objective response in their injected lesions, 20% CR + 20% PR, with locoregional disease control, CR + PR + SD, achieved in 75% of subjects. Fifteen percent of subjects exhibited objective response in their bystander lesions, with a strong correlation between response of target and bystander lesions: 25% of subjects experiencing objective response of their target lesions exhibited objective response of their bystander lesions, and 100% exhibited disease control in their bystander lesions. In contrast, only 8% of subjects failing to experience objective response of their target lesions exhibited objective response of their bystander lesions, and 75% exhibited disease progression. Expanded phase 2 testing commenced in late 2007, assessing PV-10 chemoablation in 80 Stage III and IV subjects. In this study new or incompletely responsive lesions may be treated at weeks 8, 12 or 16 after initial treatment, with follow-up to 52 weeks. Initial data from this study will be presented.
Subjects 1112 Oncology and Carcinogenesis
Q-Index Code EX
Q-Index Status Provisional Code
Institutional Status Unknown
Additional Notes Presentation number: 178

 
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Created: Tue, 09 Mar 2010, 15:08:54 EST by Laura McTaggart on behalf of Faculty Of Health Sciences