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Vaccine Therapy and Cyclophosphamide in Treating Patients with Pancreatic Cancer

Trial Status: Active

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.

Inclusion Criteria

  • Have a history of surgically resected and pathologically proven adenocarcinoma of the pancreas
  • COHORTS 1, 3, AND 4: Have been a participant in Hopkins Institutional Review Board (IRB) protocol J0810, J1568, or J15237
  • COHORT 2: Have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and/or chemoradiation
  • COHORTS 1, 3, AND 4: Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least 6-12 months prior
  • Received the last anti-cancer therapy at least 28 days ago
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have provided informed consent
  • Hemoglobin >= 9 gm/dl
  • Absolute neutrophil count (ANC) >= 1500/cu mm
  • Platelets >= 100,000/cu mm
  • Absolute lymphocyte count >= 500/cu mm
  • Serum creatinine =< 2 mg/dl
  • Bilirubin =< 2.0 mg/dl, unless known Gilbert's syndrome
  • Aspartate aminotransferase (AST) =< 2 x upper limit of normal
  • Alanine aminotransferase (ALT) =< 2 x upper limit of normal
  • Amylase =< 2 x upper limit of normal
  • Alkaline (Alk) phosphatase (Phos) =< 5 x upper limit of normal
  • Agree to use adequate birth control, if of childbearing potential

Exclusion Criteria

  • Radiographic evidence of pancreatic cancer recurrence
  • Documented history of certain autoimmune diseases such as systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
  • Uncontrolled medical problems
  • Systemic steroid therapy within 28 days before vaccine administration
  • Anticipated need for systemic steroid therapy within 28 days after vaccine administration
  • Evidence of active infections
  • Pregnant
  • History of another cancer (other than pancreatic cancer) or myeloproliferative disorders in the past five years except for treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma-in-situ of the cervix
  • History of noncompliance during previous vaccination cycles with study treatment and/or monitoring which is concerning for continued noncompliance

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Lei Zheng
Phone: 410-955-8974

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 are assigned to 1 of 3 arms. Patients from the J0810 study are assigned to Arm B or Arm C based on the same treatment arm in that study, and patients from the J1568 and J15237 studies and 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 once daily (QD) 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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Lei Zheng

  • Primary ID J09100
  • Secondary IDs NCI-2010-01868, NA_00031401, CIR00005394
  • Clinicaltrials.gov ID NCT01088789