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PV-10 Chemoablation of Recurrent Breast Carcinoma

NCT00237354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-10-24

No results posted yet for this study

Summary

The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of recurrent breast carcinoma. This study will also include a preliminary assessment of response of injected lesions by histologic assessment upon lesion excision at 1-3 weeks following IL PV-10 administration. Post-excision wound healing will be assessed clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.

Conditions

Interventions

DRUG

PV-10 (rose bengal disodium 10%)

PV-10 ablation of study lesion

Sponsors & Collaborators

  • Provectus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Eric Wachter, Ph.D. · Provectus Pharmaceuticals, Inc.

  • Chris Wynne, M.D. · Oncology Service, Christchurch Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-06-30
Completion
2008-07-31

Countries

  • New Zealand

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 NCT00237354 on ClinicalTrials.gov