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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Systemic and locoregional adverse experience
5-7 weeks post dosing (4 weeks post excision)
Eric Wachter, Ph.D.
Provectus Pharmaceuticals, Inc.
United States: Food and Drug Administration