Conditions: Metastatic Pancreatic Cancer
Keywords: Cancer Cancer vaccine Listeria monocytogenes Listeria-based vaccines GVAX Cyclophosphamide Cytoxan T regulatory cells Heterologous Prime-Boost Immunotherapy Mesothelin Pancreatic cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: GVAX Pancreas intervention 2: CRS-207 intervention 3: Cyclophosphamide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: