Expanded Access Non Emergency Use Single Subject Study Protocol for Metastatic Neuroendocrine Tumor of the Pancreas (PSV2)
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A single patient protocol for intermediate grade nonfunctional metastatic pancreatic neuroendocrine disease that has exhausted all standard therapy having progressed on chemotherapy and immunotherapy.
Condition or disease
This patient will receive intratumoral injection of an oncolytic virus called PSV2 (short for Personalized Virus-2) every other week until the occurrence of immune related RECIST progression, intolerable toxicity, change to another anti-cancer treatment due to lack of apparent benefit, or personal choice.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Ability to understand and sign a written informed consent form.
Measurable or evaluable disease with least one (1) tumor that is accessible to intratumoral injection.
Eastern Cooperative Group (ECOG) performance status is 0-3 at Screening.
Acceptable liver function at Screening, as evidenced by:
Bilirubin ≤ 3.0 X upper limit of normal (ULN) since this patient has
been diagnosed with Gilbert's Disease
AST (SGOT) and ALT (SGPT) ≤ 5 X ULN.
Serum creatinine < 3 x institution upper limit of normal.
Patient has acceptable hematologic status at Screening, as evidenced by:
Absolute neutrophil count ≥ 1,500 cells/mm3; and
Platelet count ≥ 70,000/mm3; and
Hemoglobin (HGB) ≥ 8.5 g/dL.
Medically acceptable contraception.
Willingness to comply with all protocol procedures, evaluations and rescue measures.
Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.