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Neuroendocrine Tumors Metastatic to the LiverPhase 1NCT02693067

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

A Phase 1 study testing Rose bengal disodium in people with Neuroendocrine Tumors Metastatic to the Liver, run by Provectus Biopharmaceuticals, Inc. at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rose bengal disodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustralia
Study dates
Jul 2016to Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Bilirubin ≤ 1.5 times ULN.
  • Creatinine ≤ 1.5 times ULN and estimated glomerular filtration rate (eGFR) ≥ 50.
  • Thyroid Function
  • Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum thyroxine) and TSH (serum thyrotropin) ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 abnormality.
  • Renal Function
  • Subjects must have adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease, see 8 above.
  • Cardiovascular Function
  • Subjects must have adequate cardiovascular function in the opinion of the Investigator with no clinically significant uncontrolled cardiovascular disease. All subjects must have a cardiac echo performed within 12 months to exclude tricuspid incompetence ("carcinoid heart syndrome").
  • Respiratory Function
  • Subjects must have adequate respiratory function in the opinion of the Investigator with no clinically significant uncontrolled respiratory disease.
  • Immunological Function
  • Subjects must have adequate immune system function in the opinion of the Investigator with no known immunodeficiency disease.
  • Long Acting Somatostatin Analogs
  • Subjects on long acting somatostatin analogs must be stable on treatment. Somatostatin analogs are to be continued throughout the study period.
  • Informed Consent: Signed by the subject prior to screening.

Who cannot join

  • 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).
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  • 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.
  • A documented variceal hemorrhage within 4 months of screening.
  • History of human immunodeficiency virus or acquired immune deficiency syndrome.
  • The clinical or radiological presence of ascites.
  • Pregnancy
  • Female subjects who are pregnant or lactating.
  • Female subjects who have positive serum 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).

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

About this study

Official title: A Phase 1 Study to Assess the Safety, Tolerability and Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver in the Reduction of Biochemical Markers and Symptoms Caused by Secretory Products

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.

Read the detailed description

This is a single center, open-label study to evaluate the safety, tolerability, and effect on tumor growth and symptomology (clinical and biomarkers) following a single intralesional injection of PV-10 in subjects with neuroendocrine tumors metastatic to the liver. Subjects will be divided into two cohorts (up to 6 subjects in each), the first of which will receive intralesional PV-10 to one liver lesion (to a maximum dose of 15 mL PV-10) to assess safety. If safety is established, cohort two will receive treatment to all amenable lesions (to a maximum dose of 15 mL PV-10). Subjects can have further lesions treated 6 weeks after their initial treatment provided any preceding treatments with PV-10 were well tolerated.

Being tested
Rose bengal disodium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rose bengal disodiumDrug

    Also called PV-10

    Percutaneous intralesional injection to NET tumor

Study groups in NCT02693067
Study groupRoleWhat they receive
PV-10ExperimentalIntralesional rose bengal disodium (PV-10) to one or more neuroendocrine tumor metastases to the liver
Receives: Drug: Rose bengal disodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

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

    Measured: 28 days

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    Response of Injected Target and Measurable Bystander Lesions (if present) will be Tabulated

    Measured: 6 months

  2. Target Lesion Somatostatin Receptor (SSTR) Expression

    Change in SSTR Expression will be Assessed vs Baseline Values

    Measured: 6 months

  3. Change in Neuroendocrine Tumor Biomarkers

    Change in Chromogranin A (CgA) and/or 5-Hydroxyindole Acetic Acid (5-HIAA) will be Assessed vs Baseline Values

    Measured: 6 months

  4. Reduction in Major Symptoms

    Change in Major Symptoms (Diarrhea and Flushing) will be Separately Assessed using European Organization for Research and Treatment of Cancer QLQ-C30 and GI.NET21 Symptom Scores vs Baseline Values

    Measured: 6 months

  5. Reduction in Other Symptoms

    Change in Other Symptoms (including Bronchoconstriction and Abdominal Cramping) will be Separately Assessed using QLQ-C30 and GI.NET21 Symptom Scores vs Baseline Values

    Measured: 6 months

  6. Change in Peripheral Blood Mononuclear Cells (PBMC)

    Change in PBMC will be Assessed vs Baseline Values

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion1 Sep 2021
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02693067
Sponsor's protocol ID
PV-10-NET-01
Status last verified
Feb 2023
First submitted
23 Feb 2016
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40140696

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rose bengal disodium in people with Neuroendocrine Tumors Metastatic to the Liver, run by Provectus Biopharmaceuticals, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02693067, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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