A Study to Assess PV-10 Chemoablation of Cancer of the Liver
Summary
This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either recurrent hepatocellular carcinoma (HCC) or cancer metastatic to the liver. In each of two planned dose cohorts there will be three subjects. Dose escalation will occur following assessment of safety and tolerability in the first cohort.
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Cancer Metastatic to the Liver
Intervention
PV-10 (10% rose bengal disodium)
Location
Sharp Memorial Hospital
San Diego
California
United States
92123
Status
Recruiting
Source
Provectus Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00986661
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:18:58-0400
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Medical and Biotech [MESH] Definitions
Rose Bengal
A bright bluish pink compound that has been used as a dye, biological stain, and diagnostic aid.
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Krukenberg Tumor
Mucocellular carcinoma of the ovary, usually metastatic from the gastrointestinal tract, characterized by areas of mucoid degeneration and the presence of signet-ring-like cells. It accounts for 30%-40% of metastatic cancers to the ovaries and possibly 1%-2% of all malignant ovarian tumors. The lesions may not be discovered until the primary disease is advanced, and most patients die of their disease within a year. In some cases, a primary tumor is not found. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1685)
Liver Neoplasms
Tumors or cancer of the LIVER.
Mcf-7 Cells
An estrogen responsive cell line derived from a patient with metastatic human breast ADENOCARCINOMA (at the Michigan Cancer Foundation.)
