Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00521053|
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: PV-10 (10% rose bengal disodium)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||June 2012|
Drug: PV-10 (10% rose bengal disodium)
Intralesional injection for chemoablation
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|