Phase 2 Study of Intralesional PV-10 in Refractory Metastatic Melanoma.

ABSTRACT:

Purpose

This international, multicenter, single-arm trial assessed efficacy and safety of intralesional rose bengal (PV-10) in 80 patients with refractory cutaneous or subcutaneous metastatic melanoma.

Methods

Sixty-two stage III and 18 stage IV melanoma patients with disease refractory to a median of six prior interventions received intralesional PV-10 into up to 20 cutaneous and subcutaneous lesions up to four times over a 16-week period and were followed for 52 weeks. Objectives were to determine best overall response rate in injected target lesions and uninjected bystander lesions, assess durability of response, and characterize adverse events.

Results

For target lesions, the best overall response rate was 51 %, and the complete response rate was 26 %. Median time

SUBMITTER: Thompson JF 

PROVIDER: S-EPMC4458269 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature