Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)
Diakonos Oncology Corporation
Summary
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.
Description
The primary objective of this phase 1, first in human trial is to determine the safety, toxicity, and feasibility of delivering autologous DCs loaded with pancreatic adenocarcinoma lysate and mRNA to pancreatic cancer patients following surgery. After having undergone surgical resection of their PDAC (with or without prior neoadjuvant chemotherapy), patients will undergo apheresis for the manufacture of the DC therapy. Once the DC therapy has been manufactured, it will be administered by image-guided injections proximal to a lymph node near the surgical bed with concurrent use of subcutaneous…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria An individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Male or female, aged 18 years and older 3. 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. 4. Adequate kidney, liver, bone marrow function, and immune function, as follows, within…
Interventions
- BiologicalAutologous DC Therapy
Autologous DC Therapy
Locations (3)
- Baylor College of Medicine Medical Center - McNair CampusHouston, Texas
- Baylor St. Lukes Medical CenterHouston, Texas
- Dan L. Duncan Cancer Center at Baylor College of MedicineHouston, Texas