- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693067
A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
South Australia
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Woodville, South Australia, Australia, 5011
- The Queen Elizabeth Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PV-10
Intralesional rose bengal disodium (PV-10) to one or more neuroendocrine tumor metastases to the liver
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Percutaneous intralesional injection to NET tumor
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events
Time Frame: 28 days
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Incidence of Systemic and Locoregional Adverse Events will be Coded and Tabulated
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: 6 months
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Response of Injected Target and Measurable Bystander Lesions (if present) will be Tabulated
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6 months
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Target Lesion Somatostatin Receptor (SSTR) Expression
Time Frame: 6 months
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Change in SSTR Expression will be Assessed vs Baseline Values
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6 months
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Change in Neuroendocrine Tumor Biomarkers
Time Frame: 6 months
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Change in Chromogranin A (CgA) and/or 5-Hydroxyindole Acetic Acid (5-HIAA) will be Assessed vs Baseline Values
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6 months
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Reduction in Major Symptoms
Time Frame: 6 months
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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
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6 months
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Reduction in Other Symptoms
Time Frame: 6 months
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Change in Other Symptoms (including Bronchoconstriction and Abdominal Cramping) will be Separately Assessed using QLQ-C30 and GI.NET21 Symptom Scores vs Baseline Values
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6 months
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Change in Peripheral Blood Mononuclear Cells (PBMC)
Time Frame: 28 days
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Change in PBMC will be Assessed vs Baseline Values
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28 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV-10-NET-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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