J09100- A safety and feasibility trial of boost vaccinations of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the GM-CSF gene given alone or in combination with either a single intravenous dose or daily metronomic oral doses
Johns Hopkins Kimmel Cancer Center in Baltimore
To evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the GM-CSF gene alone or given 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 head, neck, tail or the uncinate process of the pancreas.
1.History of surgically resected pathologic stage 1 and 2 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas.2.Have previously participated in our Hopkins IRB protocol application number 00-01-58-58 study (SKCCC J0810).3.Have no radiographic evidence of pancreatic cancer disease recurrence.4.Have not received any anti-cancer therapy in the past 28 days.
Study participants will be recruited from our prior three arm neoadjuvant vaccination study (J0810) with or without low dose cyclophosphamide. The vaccination boosts will be offered as a continuation of care. Patients will remain on the same arm as the J0810 where they have received the parental vaccine. The first boost vaccine will be given no sooner than six months (+/- 1 month) after the last prime vaccination. The vaccine will be administered for all arms once every six months (+/- 1month) after the previous vaccine until ten years have passed, the subject no longer meets the eligibility criteria, no longer wishes to participate in the study, or the vaccine supply is exhausted. Eligible subjects will receive by intradermal administration the pancreatic tumor vaccine consisting of two irradiated, allogenic pancreatic tumor cell lines transfected with granulocyte macrophage-colony stimulating factor (GM-CSF) gene with or without low dose cyclophosphamide. Arm A participants will receive the pancreatic cancer vaccine alone. Arm B participants will be vaccinated and receive a single low dose of cyclophosphamide (200mg/m2) intravenously one day prior to vaccination. Participants in Arm C will receive cyclophosphamide 50 mg once a day starting from 28 days prior to day 1of vaccination till 28 days post vaccination.
01/19/2020 05:03 AM