A Trial of Boost Vaccinations of Pancreatic Tumor Cell Vaccine

Summary

Participation Requirements

Description

Primary Objective: 1. To evaluate the safety and feasibility of long term 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 of cyclo...

Primary Objective: 1. To evaluate the safety and feasibility of long term 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 of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the head, neck, or uncinate process of the pancreas. Secondary Objective: To assess the effect of boost vaccinations and long-term treatment of immune modulating doses of cyclophosphamide on the number, repertoire and avidity of peripheral mesothelin-specific CD8+ T cells. To estimate disease-free and overall survival of surgically resected pancreatic adenocarcinoma patients treated with vaccine boosts with or without low dose cyclophosphamide. Eligible subjects will receive by intradermal administration the pancreatic tumor vaccine consisting of two irradiated, allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene with or without low dose cyclophosphamide. Study participants will be recruited from our prior three arm neoadjuvant vaccination with or without low dose cyclophosphamide trial and vaccine naive patients. The vaccination boosts will be offered as a continuation of care. Patients from the J0810 study will remain on the same arm as the J0810 study where they have received the parental vaccine. The first vaccine boost will be given no sooner than six months after the last prime vaccination. The vaccine will be administered for all arms once every six months after the previous vaccine until five years have passed and then once every 12 months until 10 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. Arm A participants will receive the pancreatic cancer vaccine alone. Arm B participants will be vaccinated and receive a single low-dose of cyclophosphamide (200 mg/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 1 of vaccination till 28 days post vaccination. Vaccine naive patients will first receive three prime vaccines each one month apart and each in combination with a single low-dose of cyclophosphamide (200 mg/m2)intravenously one day prior to vaccination. Then they will receive the boost vaccines as the participant in Arm B from the J0810 study.

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