A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma

NCT00521053 Phase 2 COMPLETED Results posted

The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. Additional objectives are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection.

Details

Lead sponsor	Provectus Pharmaceuticals
Phase	Phase 2
Status	COMPLETED
Enrolment	80
Start date	2007-09
Completion	2012-06

Conditions

• Melanoma

Interventions

• PV-10 (10% rose bengal disodium)

Primary outcomes

• Objective Response Rate (ORR) of PV-10 Treated Lesions — 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.

Countries

United States, Australia