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

Phase 1
18 Years
85 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Systemic and locoregional adverse experience

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Eric Wachter, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Provectus Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

July 2008

Related Keywords:

  • Breast Cancer
  • Recurrent soft tissue breast carcinoma
  • Breast Neoplasms
  • Carcinoma