Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer
Metastatic Pancreatic Cancer
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Cancer, Cancer vaccine, Listeria monocytogenes, Listeria-based vaccines, GVAX, Cyclophosphamide, Cytoxan, T regulatory cells, Heterologous Prime-Boost, Immunotherapy, Mesothelin, 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
Sites / Locations
- H. Lee Moffitt Cancer Center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
- National Cancer Institute
- Washington University School of Medicine
- NYU Langone Medical Center
- Herbert Irving Comprehensive Cancer Center of Columbia University
- Duke University Medical Center
- Providence Portland Medical Center
- University of Pittsburgh Medical Center
- Virginia Mason Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cy/GVAX + CRS-207
Cy/GVAX
200 mg per square meter (mg/m^2) cyclophosphamide (Cy) administered by intravenous (IV) infusion on Day 1 of Weeks 1 and 4; GVAX pancreas vaccine (GVAX, 5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1 and 4; CRS-207 (1 × 10e9 colony forming units [CFU]) administered by IV infusion on Day 1 of Weeks 7, 10, 13, 16.
200 mg/m^2 Cy administered by IV infusion on Day 1 of Weeks 1, 4, 7, 10, 13, 16; GVAX (5 × 10e8 cells) administered by intradermal injection on Day 2 of Weeks 1, 4, 7, 10, 13, 16.