A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene
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.
1. 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.
2. To estimate disease-free and overall survival of surgically resected pancreatic
adenocarcinoma patients treated with vaccine boosts with or without low dose
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 (+/- 1 month) after the last prime vaccination. The vaccine will be administered for
all arms once every six months (+/- 1 month) 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. 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.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free overall survival.
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
total of 13 years with 6 months between vaccines.
Lei Zheng, MD
Johns Hopkins University
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|