A Study to Assess PV-10 Chemoablation of Cancer of the Liver
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
1 other identifier
interventional
78
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2009
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 30, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedNovember 2, 2022
October 1, 2022
13.2 years
September 24, 2009
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of hepatic administration of PV-10
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
28 days
Secondary Outcomes (5)
PV-10 distribution
3 months
Objective response rate (ORR)
3 months
Changes in markers of hepatic function
3 months
Pharmacokinetics of PV-10
28 days
Overall survival
Assessed every 3 months for up to 100 months
Other Outcomes (1)
Exploratory Correlative Endpoints
28 days
Study Arms (1)
PV-10 Injection (Intralesional)
EXPERIMENTALSubjects in each of three cohorts will receive a single dose of PV-10 to one Target Lesion.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
- At least one Target Lesion determined to be amenable to percutaneous injection by the treating physician.
- Target Lesion(s) must have measurable disease, defined as a unidimensionally measurable lesion ≥ 1.0 cm in longest diameter by helical CT; the maximum diameter of Target Lesion(s) 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.
You may not qualify if:
- 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).
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Sharp Memorial Hospital
San Diego, California, 92123, United States
Florida Hospital Tampa
Tampa, Florida, 33613, United States
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric Wachter, PhD
Provectus Biopharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 30, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2022
Study Completion
February 1, 2023
Last Updated
November 2, 2022
Record last verified: 2022-10