A Study to Assess PV-10 Chemoablation of Cancer of the Liver
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ClinicalTrials.gov Identifier: NCT00986661 |
Recruitment Status
:
Recruiting
First Posted
: September 30, 2009
Last Update Posted
: April 26, 2018
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Condition or disease | Intervention/treatment | Phase |
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Cancer Metastatic to the Liver Hepatocellular Carcinoma | Drug: PV-10 (10% rose bengal disodium) | Phase 1 |

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 |

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.
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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).
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- 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 ]
- 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 ]

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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).

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 ClinicalTrials.gov identifier (NCT number): NCT00986661
Contact: Paul M Goldfarb, M.D. | 858 637 7888 | gldfrb@aol.com | |
Contact: Eric Wachter, Ph.D. | 865-769-4011 ext 23 | wachter@pvct.com |
United States, California | |
Sharp Memorial Hospital | Recruiting |
San Diego, California, United States, 92123 | |
Contact: Amy King 858-939-5052 Amy.King@sharp.com | |
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 heather.bingaman@ahss.org | |
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 Alyse.LaLiberte@sluhn.org | |
Contact: Robyn Rex, RN, OCN, CCRP 484-503-4152 robyn.rex@sluhn.org | |
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 rhonda.j.combs@vanderbilt.edu | |
Contact: Melissa Ford, MSN, PhD, RN 615-875-7143 melissa.b.ford@vanderbilt.edu | |
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 gcbalmes@mdanderson.org | |
Principal Investigator: Sapna Patel, MD |
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. |
ClinicalTrials.gov Identifier: | NCT00986661 History of Changes |
Other Study ID Numbers: |
PV-10-LC-01 |
First Posted: | September 30, 2009 Key Record Dates |
Last Update Posted: | April 26, 2018 |
Last Verified: | April 2018 |
Keywords provided by Provectus Pharmaceuticals ( Provectus Biopharmaceuticals, Inc. ):
melanoma uveal ocular mUM mOM OM UM |
pancreatic colon colorectal lung metastatic carcinoid neuroendocrine |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Hepatocellular Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |