PV-10 for metastatic melanoma

Journal of Drugs in Dermatology, March, 2008 by Marissa Heller

A phase II clinical trial for PV-10 (Provecta[TM]) in the treatment of stage III and stage IV metastatic melanoma has begun a recruitment expansion to a second trial center. Provecta is an anticancer medication that has received orphan drug designation in the US. Provectus Pharmaceuticals, Inc plans to continue to expand this clinical trial to additional sites in Australia as well as the US. In total, this multicenter study plans to evaluate the efficacy of Provecta in 80 patients.

In phase I trials of Provecta, the medication was tested in 20 patients with a total of more than 100 metastatic melanoma tumors. The medication was well tolerated with only mild side effects. In the current phase II trial, Provecta will be injected into up to 20 tumors in each patient, and additional injections may be made 8 to 16 weeks after the initial injection, if the investigator deems this to be necessary. Patients will then be followed for 1 year after treatment, and will be assessed for response rate, progression-free survival, quality of life, and safety.