Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)
This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC.
∙ An individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Male or female, aged 18 years and older
• Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +/- radiation prior to resection.
• Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
‣ Hemoglobin ≥ 8.0 gm/dL
⁃ Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
⁃ Platelet count ≥ 75,000 /mm3
⁃ Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
⁃ Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
• ECOG performance status ≤ 2.
• For women of childbearing potential (WOCBP): use of highly effective contraception must be discussed with participants. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and continue for at least 12 weeks after her last vaccination.
• WOCBP must have a negative serum pregnancy prior to vaccination
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination.
• Patient must agree to not donate blood for up to 90 days after last vaccination.