PV-10 Chemoablation of Recurrent Breast Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00237354
First received: October 7, 2005
Last updated: October 22, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: PV-10 (rose bengal disodium 10%)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:
  • Systemic and locoregional adverse experience [ Time Frame: 5-7 weeks post dosing (4 weeks post excision) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Histopathologic response of PV-10 injected lesions [ Time Frame: 7-21 days post dosing ] [ Designated as safety issue: No ]
  • Wound healing of PV-10 injected lesions [ Time Frame: 5-7 weeks post dosing (4 weeks post excision) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: October 2005
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PV-10 (rose bengal disodium 10%)
    PV-10 ablation of study lesion
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237354

Locations
New Zealand
Canterbury BreastCare
Christchurch, New Zealand
Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
Study Director: Eric Wachter, Ph.D. Provectus Pharmaceuticals, Inc.
Principal Investigator: Chris Wynne, M.D. Oncology Service, Christchurch Hospital
  More Information

No publications provided

Responsible Party: Eric Wachter, Ph.D., Provectus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00237354     History of Changes
Other Study ID Numbers: PV-10-BC-04
Study First Received: October 7, 2005
Last Updated: October 22, 2008
Health Authority: United States: Food and Drug Administration
New Zealand: Medicines and Devices Safety Authority

Keywords provided by Provectus Pharmaceuticals:
Recurrent soft tissue breast carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014