PV-10 Chemoablation of Recurrent Breast Carcinoma - Full Text View

Sponsored by:	Provectus Pharmaceuticals
Information provided by:	Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00237354

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 I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma

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:

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

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

Responsible Party:	Provectus Pharmaceuticals, Inc. ( Eric Wachter, Ph.D. )
Study ID Numbers:	PV-10-BC-04
Study First Received:	October 7, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00237354
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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009