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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Percutaneous intralesional injection to NET tumor
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Number of Participants with Adverse Events
Incidence of Systemic and Locoregional Adverse Events will be Coded and Tabulated
Time frame: 28 days
Objective Response Rate (ORR)
Response of Injected Target and Measurable Bystander Lesions (if present) will be Tabulated
Time frame: 6 months
Target Lesion Somatostatin Receptor (SSTR) Expression
Change in SSTR Expression will be Assessed vs Baseline Values
Time frame: 6 months
Change in Neuroendocrine Tumor Biomarkers
Change in Chromogranin A (CgA) and/or 5-Hydroxyindole Acetic Acid (5-HIAA) will be Assessed vs Baseline Values
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
Change in Peripheral Blood Mononuclear Cells (PBMC)
Change in PBMC will be Assessed vs Baseline Values
Time frame: 28 days
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