Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma|
- Objective Response Rate (ORR) of PV-10 Treated Lesions [ Time Frame: 52 weeks ]Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.
- Objective Response Rate of Untreated Bystander Lesions [ Time Frame: 52 weeks ]Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for designated, untreated cutaneous or subcutaneous bystander lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all bystander lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of bystander lesions; Objective Response Rate (ORR) = %CR + %PR.
- Progression Free Survival (PFS) [ Time Frame: 52 weeks ]Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or significant worsening of non-target disease (e.g., a measurable increase in non-target lesions or the appearance of new lesions) indicative of disease progression.
- Overall Survival [ Time Frame: 52 weeks ]1-year survival
|Study Start Date:||September 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Drug: PV-10 (10% rose bengal disodium)
Intralesional injection for chemoablation
This is a multicenter, open-label, single-agent study. Subjects with at least one melanoma lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound will receive intralesional injection of PV-10 into each of up to twenty (20) Study Lesions. Additionally, one to two measurable Bystander Lesions may remain untreated and will be followed for assessment of bystander response.
To accurately reflect anticipated clinical use, repeat dosing of treated lesions will be allowed at the Investigator's discretion at weeks 8, 12 and 16 following initial treatment for those lesions not exhibiting complete response. Subjects will be followed for 52 weeks following initial treatment with PV-10.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521053
|United States, California|
|California Pacific Medical Center|
|San Francisco, California, United States, 94115|
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Pennsylvania|
|St Luke's Hospital & Health Network|
|Bethlehem, Pennsylvania, United States, 18015|
|United States, Texas|
|M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Australia, New South Wales|
|Sydney Melanoma Unit|
|Sydney, New South Wales, Australia, 2050|
|Princess Alexandra Hospital|
|Woolloongabba, Queensland, Australia, 4102|
|Australia, South Australia|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Principal Investigator:||John F Thompson, MD||Sydney Melanoma Unit|