A randomized three-arm, neoadjuvant and adjuvant, feasibility and toxicity study of a GM-CSF secreting allogeneic pancreatic cancer vaccine administered either alone, or in combination with either a single intravenous dose, or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas
To evaluate the safety and feasibility of administration of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the GM-CSF gene alone, or given with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resectable adenocarcinoma of the head, neck, or uncinate process of the pancreas as neoadjuvant and adjuvant treatment.
- newly diagnosed, surgically resectable, suspected pancreatic adenocarcinoma of the head, neck, or uncinate process of the pancreas- no radiographic evidence of pancreatic cancer disease recurrence during the study-have not received any anti-cancer therapy in the past 28 days-have not received any cancer immunotherapy in the past
Patients will be randomized to one of three arms: -Arm A: Participants will receive a neo-adjuvant vaccination two weeks prior to surgery. A second vaccination will be administered 6-10 weeks following surgery. The patient will then undergo adjuvant chemoradiation therapy per standard of care guidelines. 1-2 months following chemoradiation, patients will undergo four additional vaccine cycles repeated every 28 days.-Arm B: The same as Arm A however participants enrolled in this arm will also receive Cyclophosphamide intravenoulsy 1 day prior to receiving each vaccination. -Arm C: The same as Arm A however prior to surgery, participants will also receive oral Cyclophosphamide twice daily on day 1-7 (day 1 being the day of vaccination). Following surgery, for cycle #2-#6 participants will also receive oral Cyclophosphamide on day 1-7 and from day 15-21. For all arms, disease is re-assessed prior to cycle 2, 3 and at the end of cycle #6.
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