A study comparing the outcome of advanced skin Melanoma cancer treated with a test drug given locally into the affected area versus standard of care treatments.

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.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • At least 1 cutaneous Target Lesion ? 10 mm in longest diameter
  • No lesion > 30 mm in longest diameter
  • No more than 20 lesions
  • Can not have severe peripheral vascular disease
  • Can not have had Radiation Therapy
  • Chemotherapy
  • Immunotherapy or Local Treatment within 6 of initial study treatment
  • Must be a candidate for at least one of the comparator drug listed in the protocol

What is involved

  • Physical exam
  • Questionnaires
  • Blood draw
  • Pregnancy test
  • Photography of lesions
  • Tumor measurements
  • CT scan
  • MRI
  • Electronic diary
  • Administration of treatment drug

Compensation

None

Contact Information

Study Coordinator
Joyce Fenstermaker
Email
jfenster@wakehealth.edu
Phone
336-713-3155
Principal Investigator
Dr. Paul Savage

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.