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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00986661
Recruitment Status : Recruiting
First Posted : September 30, 2009
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
Provectus Pharmaceuticals ( Provectus Biopharmaceuticals, Inc. )

Brief 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 (a) hepatocellular carcinoma (HCC) that is not amenable to resection, transplant or other potentially curative therapy or (b) cancer metastatic to the liver.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. 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 :
  1. Lesion distribution and retention of PV-10 following injection. [ Time Frame: 3 months ]
  2. Objective response rate (ORR) of Target and measurable Bystander Lesions (if present) by 2D EASL criteria. [ Time Frame: 3 months ]
  3. Changes in markers of hepatic function, including ALP, ALT, AST, total bilirubin and GGT. [ Time Frame: 3 months ]
  4. 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 ]
  5. 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 ]

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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00986661

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

United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Amy King    858-939-5052   
Principal Investigator: Kristin Rice, M.D.         
United States, Florida
Florida Hospital Tampa Recruiting
Tampa, Florida, United States, 33613
Contact: Heather Bingaman, BS    813-615-7068   
Principal Investigator: Alexander Rosemurgy, M.D.         
United States, Pennsylvania
St Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Alyse M LaLiberte, MPH    484-503-4151   
Contact: Robyn Rex, RN, OCN, CCRP    484-503-4152   
Principal Investigator: Sanjiv Agarwala, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Rhonda Combs, LPN    615-322-2260   
Contact: Melissa Ford, MSN, PhD, RN    615-875-7143   
Principal Investigator: Daniel Brown, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gener Balmes, RN, CCRP    713-794-4153   
Principal Investigator: Sapna Patel, 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

Responsible Party: Provectus Biopharmaceuticals, Inc. Identifier: NCT00986661     History of Changes
Other Study ID Numbers: PV-10-LC-01
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

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