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PV-10 Chemoablation of Recurrent Breast Carcinoma

Sponsor
Provectus Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00237354
Collaborator
(none)
15
Enrollment
1
Location
33
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PV-10 (rose bengal disodium 10%)
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Systemic and locoregional adverse experience [5-7 weeks post dosing (4 weeks post excision)]

Secondary Outcome Measures

  1. Histopathologic response of PV-10 injected lesions [7-21 days post dosing]

  2. Wound healing of PV-10 injected lesions [5-7 weeks post dosing (4 weeks post excision)]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00237354
Other Study ID Numbers:
  • PV-10-BC-04
First Posted:
Oct 12, 2005
Last Update Posted:
Oct 24, 2008
Last Verified:
Oct 1, 2008
Keywords provided by , ,
Recurrent soft tissue breast carcinoma
Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms

Study Results

No Results Posted as of Oct 24, 2008