Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting
Condition: 2nd-line, 3rd-line and Greater Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: GVAX Pancreas Vaccine; CRS-207; Chemotherapy; cyclophosphamide
Intervention description: Investigator's choice of one of the following commercially available products: gemcitabine; capecitabine; fluorouracil with or without leucovorin; irinotecan; or erlotinib.
Intervention MeSH terms: Cyclophosphamide; Pancrelipase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; cancer vaccine; Listeria monocytogenes; Listeria-based vaccine; GVAX; cyclophosphamide; Cytoxan; immunotherapy; mesothelin

Summary:

      Test the safety, immune response and efficacy of GVAX pancreas vaccine (with
      cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with
      previously treated metastatic pancreatic adenocarcinoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically proven malignant adenocarcinoma of the pancreas; measurable
             disease is not required, mixed histology is not allowed; subjects must have metastatic
             disease

          -  2nd line, 3rd line or greater

          -  At least 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Anticipated life expectancy >12 weeks

          -  For women and men of childbearing potential, a medically acceptable method of highly
             effective contraception (oral hormonal contraceptive, condom plus spermicide, or
             hormone implants) must be used throughout the study period and for 28 days after their
             final vaccine administration. A barrier method of contraception must be employed by
             all subjects (male and female), regardless of other methods.

          -  Have adequate organ function as defined by specified laboratory values

        Exclusion Criteria:

          -  Allergy to both penicillin & sulfa or suspected hypersensitivity to
             granulocyte-macrophage colony stimulating factor (GM-CSF), dimethyl sulfoxide, fetal
             bovine serum, trypsin, yeast, glycerol or other component of the therapy options

          -  Known history or evidence of brain metastases, immunodeficiency disease or
             immunocompromised state or history of autoimmune disease requiring systemic steroids
             or other immunosuppressive treatment

          -  Have any evidence of hepatic cirrhosis or clinical or radiographic ascites

          -  Have prosthetic heart valves, major implant or device placed in the last 12 months or
             history of infection with implant/device that cannot be easily removed

          -  Rapidly progressing disease

          -  Clinically significant and/or malignant pleural effusion

          -  Received prior GVAX pancreas vaccine or CRS-207

          -  Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring
             within 28 days prior to receiving study drug, or planned surgery requiring general
             anesthesia

          -  Infection with HIV or hepatitis B or C at screening

          -  Valvular heart disease that requires antibiotic prophylaxis for prevention of
             endocarditis

          -  Pregnant or breastfeeding

          -  Unable to avoid close contact with another individual known to be at high risk of
             listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the
             course of CRS-207 treatment until completion of antibiotic regimen

          -  Conditions, including alcohol or drug dependence, intercurrent illness, or lack of
             sufficient peripheral venous access, that would affect the patient's ability to comply
             with study visits and procedures