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A Study to Assess PV-10 Chemoablation of Cancer of the Liver

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Provectus Pharmaceuticals
Information provided by (Responsible Party):
Provectus Pharmaceuticals ( Provectus Biopharmaceuticals, Inc. ) Identifier:
First received: September 24, 2009
Last updated: October 29, 2016
Last verified: October 2016
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 (a) hepatocellular carcinoma (HCC) that is not amenable to resection, transplant or other potentially curative therapy or (b) cancer metastatic to the liver.

Condition Intervention Phase
Cancer Metastatic to the Liver
Hepatocellular Carcinoma That is Not Amenable to Resection, Transplant or Other Potentially Curative
Drug: PV-10 (10% rose bengal disodium)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma Not Amenable to Resection or Transplant

Resource links provided by NLM:

Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:
  • Safety. Systemic and locoregional Adverse Events (AEs) will be graded by CTCAE v4.0 and coded according to MedDRA. AE data for all subjects in the 1st cohort will be assessed prior to dose escalation. Final assessment use AE data for all subjects. [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Lesion distribution and retention of PV-10 following injection. [ Time Frame: 3 months ]
  • Objective response rate (ORR) of Target and measurable Bystander Lesions (if present) by 2D EASL criteria. [ Time Frame: 3 months ]
  • Changes in markers of hepatic function, including ALP, ALT, AST, total bilirubin and GGT. [ Time Frame: 3 months ]
  • Pharmacokinetics of PV-10 in the bloodstream following intralesional injection. Samples will be obtained immediately prior to PV-10 injection and at 2, 4, 8, 24 and 72 hours, and 7, 14 and 28 days to assess uptake and excretion of PV-10. [ Time Frame: 28 days ]
  • Pharmacokinetics of sorafenib in the bloodstream following intralesional injection. Samples will be obtained immediately prior to PV-10 injection and at 2, 4, 8, 24 and 72 hours, and 7, 14 and 28 days to assess impact of PV-10 on sorafenib levels. [ Time Frame: 28 days ]

Estimated Enrollment: 66
Study Start Date: October 2009
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PV-10 Injection (Intralesional)
Subjects in each of three cohorts will receive a single dose of PV-10 to one Target Lesion.
Drug: PV-10 (10% rose bengal disodium)
Subjects will receive a single injection of PV-10 to a single Target Lesion (0.25 mL PV-10 per cc lesion volume, Lv, or 0.50 mL PV-10 per cc Lv).

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older, males and females.
  • Histologically or cytologically confirmed, or clinically diagnosed based on currently accepted standards, cancer metastatic to the liver or HCC that is not amenable at the time of enrollment to resection, transplant or other potentially curative therapy.
  • The Target Lesion must be determined to be amenable to percutaneous injection by the treating physician.
  • The Target Lesion must have measurable disease, defined as a unidimensionally measurable lesion ≥ 1.0 cm in longest diameter by helical CT; the maximum diameter of the Target Lesion shall be ≤ 4.9 cm.
  • Performance status of Karnofsky scale 60%-100% or ECOG performance scale 0-2.
  • Life expectancy ≥ 12 weeks.
  • Hematopoietic Function: WBC ≥ 2,500/mm3; ANC ≥ 1000/mm3; Hemoglobin ≥ 8 g/dL; Platelet count ≥ 50,000/mm3; Coagulation: INR ≤ 1.3.
  • AST and ALT < 5 times ULN; ALP < 5 times ULN; Bilirubin ≤ 1.5 times ULN; Creatinine ≤ 1.5 times ULN and eGFR ≥ 50.
  • Thyroid Function: Total T3 or free T3, total T4 or free T4 and THS ≤ CTCAE Grade 2 abnormality.
  • Renal Function: Adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease.
  • Cardiovascular Function: Adequate cardiovascular function in the opinion of the Investigator with no clinically significant uncontrolled cardiovascular disease.
  • Respiratory Function: Adequate respiratory function in the opinion of the Investigator with no clinically significant uncontrolled respiratory disease.
  • Immunological Function: Adequate immune system function in the opinion of the Investigator with no known immunodeficiency disease.
  • Informed Consent: Signed by the subject prior to screening.

Exclusion Criteria:

  • Target Lesion(s) must not be contiguous with, encompass or infiltrate major blood vessels.
  • Primary HCC amenable to resection, transplant or other potentially curative therapy.
  • Surgery: Subjects who have received hepatic surgery, ablation or chemoembolization within 4 weeks of PV-10 administration.
  • Radiation Therapy: Hepatic radiation within 4 weeks of PV-10 administration.
  • Chemotherapy: Chemotherapy within 4 weeks of PV-10 administration (6 weeks for nitrosoureas or mitomycin C). Subjects with HCC who have been on a stable dose of sorafenib for at least 4 weeks will be candidates for enrollment in Expansion Cohort 2.
  • Investigational Agents: Investigational agents within 4 weeks (or 5 half-lives) of PV-10 administration.
  • Phototoxic or Photosensitizing Agents: Concomitant agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of PV-10 administration.
  • Concurrent or Intercurrent Illness: Impaired wound healing due to diabetes; Significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would compromise Subject safety or compliance or interfere with interpretation of the study; Uncontrolled thyroid disease or cystic fibrosis; Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (with the exception of the presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders; Current encephalopathy or current treatment for encephalopathy; Variceal bleeding requiring hospitalization or transfusion within 4 months of screening; History of human immunodeficiency virus or acquired immune deficiency syndrome; The clinical presence of ascites.
  • Pregnancy: Female subjects who are pregnant, lactating or have positive serum β HCG pregnancy test taken within 7 days of PV-10 administration; Fertile subjects who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00986661

Contact: Paul M Goldfarb, M.D. 858 637 7888

United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Lisa Obregon, RN, BSN, OCN    858-939-5052   
Principal Investigator: Paul Goldfarb, M.D.         
United States, Florida
The Southeastern Center for Digestive Disorders & Pancreatic Cancer Recruiting
Tampa, Florida, United States, 33613
Contact: Lindsey Bergman    813-615-7068    Lindsey Bergman <Lindsey.Bergman@AHSS.ORG>   
Principal Investigator: Alexander Rosemurgy, M.D.         
United States, Pennsylvania
St Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Rose Cabral    484-503-4151    Rosemarie Cabral <>   
Principal Investigator: Sanjiv Agarwala, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Melissa Ford, MSN, PhD, RN    615-875-7143   
Principal Investigator: Daniel Brown, MD         
Sponsors and Collaborators
Provectus Biopharmaceuticals, Inc.
Study Director: Eric Wachter, Ph.D. Provectus Biopharmaceuticals, Inc.
Principal Investigator: Paul M Goldfarb, M.D. Sharp Clinical Oncology Research
  More Information

Responsible Party: Provectus Biopharmaceuticals, Inc. Identifier: NCT00986661     History of Changes
Other Study ID Numbers: PV-10-LC-01
Study First Received: September 24, 2009
Last Updated: October 29, 2016

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on May 24, 2017