What we are studying
PV-10 consists of a red dye called rose bengal that is dissolved in a sterile salt solution. Previous laboratory studies have shown that PV-10 gets into tumor cells without getting into normal cells and causes tumor cells to die. In earlier studies of people with locally advanced cutaneous melanoma, some melanoma tumors that were injected with PV-10 got smaller or went away. PV-10 has been tested in approximately 200 people with melanoma.
In this study, the study doctor will give PV-10 to some people to see if it is safe and tolerable and can help them. Another aim of this study is to find out if receiving PV-10 is better than a drug called talimogene laherparepvec (also called Imlygic®), which is injected into melanoma tumors or the chemotherapy drugs dacarbazine or temozolomide for treating melanoma. The FDA has approved dacarbazine and Imlygic to treat melanoma. Temozolomide has been approved by the FDA to treat brain cancer, but it is sometimes used to treat other types of cancer, including melanoma. The researchers also want to find out about the symptoms and quality of life of study participants.
About 225 adults 18 years or older with locally advanced cutaneous melanoma will be in this study including approximately 6 people at this research site. Two out of every three participants will receive PV-10 and one out of every three will receive dacarbazine or temozolomide. You do not have to be in this study to receive dacarbazine or temozolomide.
Participants will be in the study for up to 2-1/2 years depending on when they enter the study and how their melanoma responds to treatment.