Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: GVAX Pancreas; CRS-207; Cyclophosphamide
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: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Cancer vaccine; Listeria monocytogenes; Listeria-based vaccines; GVAX; Cyclophosphamide; Cytoxan; T regulatory cells; Heterologous Prime-Boost; Immunotherapy; Mesothelin; Pancreatic cancer

Summary:

      Test the safety, immune response and efficacy of GVAX pancreas vaccine (with
      cyclophosphamide) and CRS-207 compared to GVAX pancreas vaccine (with cyclophosphamide) alone
      in adults who have failed or refused prior treatment for metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically proven malignant adenocarcinoma of the pancreas; measurable
             disease is not required. (Subjects with mixed histology will be included if the
             predominant component is adenocarcinoma. Subjects must have metastatic disease.)

          -  Have received or refused at least one chemotherapy regimen

          -  At least 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Anticipated life expectancy of >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.)

          -  Be willing and able to give written informed consent, and be able to comply with all
             study procedures

          -  Have adequate organ function as defined by specified laboratory values

        Exclusion Criteria:

          -  Currently have or have history of certain study-specified heart, liver, kidney, lung,
             neurological, immune or other medical conditions

          -  Known history or evidence of brain metastases

          -  Have any evidence of hepatic cirrhosis or clinical or radiographic ascites

          -  Have clinically significant and/or malignant pleural effusion

          -  Known or suspected hypersensitivity to any component of GVAX Pancreas vaccine or
             CRS-207, or known allergy to both penicillin and sulfa

          -  Received an investigational product within 28 days of study treatment or planned to
             receive within 28 days after vaccine administration

          -  Used any systemic steroids within 28 days of study treatment

          -  Use more than 3 g/d of acetaminophen

          -  Prosthetic joint or other artificial implant or device that cannot be easily removed
             (there are some exceptions)

          -  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

          -  Any immunodeficiency disease or immunocompromised state or active autoimmune disease
             or history of autoimmune disease requiring systemic steroids or other
             immunosuppressive treatment

          -  Be 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