A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver

NCT02693067 | Unknown Phase 1

• 1 other identifier: PV-10-NET-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to determine the safety, tolerability and reduction of biochemical markers (Chromogranin A or, if deemed appropriate, 5-hydroxyindoleaceticacid) and troublesome symptoms (particularly diarrhea and flushing) of intralesional injection of PV-10 in subjects with NET metastatic to the liver that are not amenable to resection or other potentially curative therapy.

Conditions

Neuroendocrine Tumors Metastatic to the Liver

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  Incidence of Systemic and Locoregional Adverse Events will be Coded and Tabulated

  28 days

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  6 months

• Target Lesion Somatostatin Receptor (SSTR) Expression

  6 months

• Change in Neuroendocrine Tumor Biomarkers

  6 months

• Reduction in Major Symptoms

  6 months

• Reduction in Other Symptoms

  6 months

Study Arms (1)

PV-10

EXPERIMENTAL

Intralesional rose bengal disodium (PV-10) to one or more neuroendocrine tumor metastases to the liver

Drug: Rose bengal disodium

Interventions

Rose bengal disodium DRUG

Percutaneous intralesional injection to NET tumor

Also known as: PV-10

PV-10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older, males and females.
• Histologically or cytologically confirmed, or clinically diagnosed based on currently accepted standards, NET tumors metastatic to the liver that are not amenable at the time of enrolment to resection, transplant or other potentially curative therapy. Patients must have at least one common NET symptom (European Organization for Research and Treatment of Cancer GI.NET21 instrument score of 2 or more at baseline) including: flushing, diaphoresis, diarrhea, abdominal discomfort, hyperacidity, dyspnea or palpitations.
• The Target Lesion(s) must be determined to be amenable to percutaneous injection by the treating physician.
• The Target Lesion(s) must have measurable disease, defined as a unidimensionally measurable lesion ≥ 1.0 cm in longest diameter by helical computed tomography (CT); the maximum diameter of any Target Lesion should be ≤ 3.9 cm. These lesions should also overexpress SSTR. If the lesion is negative on positron emission tomography-computed tomography (PET/CT), there is no need to perform further PET/CT scans.
• Performance status of Karnofsky scale 60%-100% or Eastern Cooperative Oncology Group (ECOG) performance scale 0-2.
• Life expectancy ≥ 6 Months.
• Hematopoietic Function
• White blood cells (WBC) ≥ 2,500/mm3.
• Absolute neutrophil count (ANC) ≥ 1000/mm3.
• Hemoglobin ≥ 8 g/dL.
• Platelet count ≥ 50,000/mm3.
• Coagulation: international normalized ratio (INR) ≤ 1.3.
• Blood Chemistry
• Aspartate transaminase (AST) and alanine transaminase (ALT) \< 5 times Upper Limit of Normal (ULN).
• Alkaline phosphatase (ALP) \< 5 times ULN.

You may not qualify if:

• Target Lesion(s) must not be contiguous with, encompass or infiltrate major blood vessels.
• Liver metastases amenable to resection, transplant or other potentially curative therapy.
• Subjects who have received hepatic surgery, ablation or chemoembolization within 4 weeks of PV-10 administration.
• Radiation Therapy • Subjects who have received hepatic radiation within 4 weeks of PV-10 administration.
• Chemotherapy
• Subjects who have received chemotherapy within 4 weeks of PV-10 administration (6 weeks for nitrosoureas or mitomycin C).
• Investigational Agents
• Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of PV-10 administration.
• Phototoxic or Photosensitizing Agents
• Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of PV-10 administration.
• Concurrent or Intercurrent Illness
• Subjects with significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of the study.
• Subjects with 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.

Sponsors & Collaborators

• Provectus Biopharmaceuticals, Inc.: lead

Study Sites (1)

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Related Publications (1)

• Price T, Depauw L, Cehic G, Wachter E, Sebben R, Reid J, Neuhaus S, Alawawdeh A, Kirkwood ID, Solanki R, McGregor M, Leopardi L, Rodrigues D, Maddern G. A phase 1 study to assess the safety, tolerability and effectiveness of PV-10 (Rose Bengal Sodium) in neuroendocrine tumours metastatic to the liver. Br J Cancer. 2025 Jun;132(10):888-896. doi: 10.1038/s41416-025-02976-9. Epub 2025 Mar 26.

  PMID: 40140696 DERIVED

MeSH Terms

Interventions

Rose Bengal B

Study Officials

• Eric Wachter, Ph.D.

  Provectus Biopharmaceuticals, Inc.

  STUDY DIRECTOR

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: February 23, 2016
• First Posted: February 26, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)