This phase II trial studies the side effects and how well vaccine therapy and cyclophosphamide work in treating patients with pancreatic cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide may be an effective treatment for pancreatic cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT01088789.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the safety and feasibility of long term boost vaccinations of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the granulocyte-macrophage colony-stimulating factor (GM-CSF) (filgrastim) 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 OBJECTIVES:
I. 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.
II. To estimate disease-free and overall survival of surgically resected pancreatic adenocarcinoma patients treated with vaccine boosts with or without low dose cyclophosphamide.
OUTLINE: Patients from the J0810 study are assigned to Arm A, Arm B, or Arm C based on the same treatment arm in that study. Patients from the J1568, J15237, and J1766 studies, as well as vaccine naive patients are assigned to Arm B.
ARM A: Patients receive allogeneic GM-CSF-secreting tumor vaccine PANC 10.05 pcDNA-1/GM-Neo and allogeneic GM-CSF-secreting tumor vaccine PANC 6.03 pcDNA-1/GM-Neo intradermally (ID) on day 1. Treatment repeats every 6 months until 5 years, and then every 12 months up to 10 years in the absence of disease progression or unacceptable toxicity.
ARM B:
PRIME VACCINATION PHASE (VACCINE NAIVE COHORT ONLY): Patients receive cyclophosphamide intravenously (IV) on day 0. Patients then receive allogeneic GM-CSF-secreting tumor vaccine PANC 10.05 pcDNA-1/GM-Neo and allogeneic GM-CSF-secreting tumor vaccine PANC 6.03 pcDNA-1/GM-Neo ID on day 1. Treatment repeats every 6 months until 5 years, and then every 12 months for up to 10 years in the absence of disease progression or unacceptable toxicity.
BOOST VACCINATION PHASE: Patients receive cyclophosphamide IV on day 0. Patients also receive allogeneic GM-CSF-secreting tumor vaccine PANC 10.05 pcDNA-1/GM-Neo and allogeneic GM-CSF-secreting tumor vaccine PANC 6.03 pcDNA-1/GM-Neo IV on day 1. Treatment repeats every 6 months for up to 5 years, then every 12 months for up to 10 years in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive cyclophosphamide orally (PO) QD on days -27 to 28. Patients also receive allogeneic GM-CSF-secreting tumor vaccine PANC 10.05 pcDNA-1/GM-Neo and allogeneic GM-CSF-secreting tumor vaccine PANC 6.03 pcDNA-1/GM-Neo IV on day 0. Treatment repeats every 6 months for up to 5 years (for patients from the J1568 and J15237 studies) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorLei Zheng
