PV-10 Chemoablation of Recurrent Breast Carcinoma

October 22, 2008 updated by: Provectus Pharmaceuticals

A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center, open label, ascending dose study. Subjects with at least one recurrent, histologically confirmed measurable soft tissue breast carcinoma who are candidates for lumpectomy (removal of the lesion from the site of recurrence in the breast or at another site) or mastectomy will receive a single intralesional injection of PV-10 into a single target lesion to uniformly infiltrate the target lesion and up to a 0.5 cm margin at a dose of up to 1.0 mL/cc lesion volume. Systemic and locoregional adverse events will be monitored over the study interval. Subject accrual and PV-10 administration will be stopped if more than 1 subject has a treatment related Grade 3 non-hematological or Grade 4 hematological toxicity within a period of two weeks after PV-10 administration.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Christchurch, New Zealand
        • Canterbury BreastCare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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
  • Thyroid Function: T3 (serum triiodothyronine), T4 (serum thyroxine) and THS (serum thyrotropin) within normal limits
  • Immunological Function: Adequate immune system function in the opinion of the investigator

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systemic and locoregional adverse experience
Time Frame: 5-7 weeks post dosing (4 weeks post excision)
5-7 weeks post dosing (4 weeks post excision)

Secondary Outcome Measures

Outcome Measure
Time Frame
Histopathologic response of PV-10 injected lesions
Time Frame: 7-21 days post dosing
7-21 days post dosing
Wound healing of PV-10 injected lesions
Time Frame: 5-7 weeks post dosing (4 weeks post excision)
5-7 weeks post dosing (4 weeks post excision)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Provectus Pharmaceuticals

Investigators

  • Principal Investigator: Chris Wynne, M.D., Oncology Service, Christchurch Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

October 24, 2008

Last Update Submitted That Met QC Criteria

October 22, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV-10-BC-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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