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Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma

NCT00521053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-08-25

Study results available
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Summary

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.

Conditions

Interventions

DRUG

PV-10 (10% rose bengal disodium)

Intralesional injection for chemoablation

Sponsors & Collaborators

  • Provectus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • John F Thompson, MD · Sydney Melanoma Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-05-31
Completion
2012-06-30

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00521053 on ClinicalTrials.gov