NCT00237354

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 24, 2008

Status Verified

October 1, 2008

Enrollment Period

2.7 years

First QC Date

October 7, 2005

Last Update Submit

October 22, 2008

Conditions

Breast Cancer

Keywords

Recurrent soft tissue breast carcinoma

Outcome Measures

Primary Outcomes (1)

  • Systemic and locoregional adverse experience

    5-7 weeks post dosing (4 weeks post excision)

Secondary Outcomes (2)

  • Histopathologic response of PV-10 injected lesions

    7-21 days post dosing

  • Wound healing of PV-10 injected lesions

    5-7 weeks post dosing (4 weeks post excision)

Interventions

PV-10 (rose bengal disodium 10%)DRUG

PV-10 ablation of study lesion

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy confirmed recurrent soft tissue breast carcinoma
  • At least one measurable target lesion at least 0.5 cm and no more than 3 cm in longest diameter
  • Performance Status: Karnofsky 70-100% or ECOG 0-2
  • Life Expectancy: At least 6 months
  • Hematopoietic:
  • White blood cell count (WBC) at least 3000/mm3
  • Absolute neutrophil count (ANC) at least 1.5 (1,500/mm3)
  • Hemoglobin at least 10 g/dL
  • Platelet count at least 100,000/mm3
  • Coagulopathy: International Normalized Ratio (INR) at least 1.5.
  • Renal Function: Creatinine = 0.05-0.11 mmol/L
  • Hepatic Function:
  • Bilirubin = 3-21 umol/L
  • AST/ALT ≤ 3 times the upper limit of normal (ULN)
  • Cardiovascular Function: No major cardiovascular disease
  • +2 more criteria

You may not qualify if:

  • Radiation therapy to study lesions within 4 weeks
  • Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin)
  • Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks
  • Investigational agents within 4 weeks (or 5 half-lives)
  • Anti-tumor vaccine therapy within 12 weeks
  • Concurrent illness:
  • Severe diabetes or extremity complications due to diabetes
  • Significant concurrent disease or illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the investigator, compromise subject safety or compliance or interfere with interpretation of study results
  • Thyroid autoregulatory dysfunction, including thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, prior radioiodine- or surgically-treated Graves' hyperthyroidism, or cystic fibrosis
  • Pregnancy or fertile female subjects who are not using effective contraception, or who are lactating
  • Known or suspected brain metastases or spinal cord compression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canterbury BreastCare

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Rose Bengal

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

FluoresceinsSpiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Eric Wachter, Ph.D.

    Provectus Pharmaceuticals, Inc.

    STUDY DIRECTOR

  • Chris Wynne, M.D.

    Oncology Service, Christchurch Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

October 24, 2008

Record last verified: 2008-10

Locations

NZ(1)