A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (with Cyclophosphamide) and CRS-207 Compared to Chemotherapy or to CRS-207 Alone in Adults with Previously-Treated Metastatic Pancreatic Adenocarcinoma
The purpose of this research study is to test whether GVAX pancreas vaccine and CRS-207 together are safe and work better than chemotherapy to treat patients with advanced pancreatic cancer who have received at least one prior chemotherapy treatment for metastatic cancer (cancer that has spread beyond the pancreas). The study will also look at whether CRS-207 alone is safe and works better than chemotherapy to treat pancreatic cancer patients who have received at least one prior chemotherapy treatment. The main goal of the study is to test how well the vaccines work in patients who have received at least 2 prior chemotherapy treatments, however, a small number of patients who have received just 1 prior chemotherapy treatment will also be included. Other goals of the study are to learn more about how the immune system responds and how your tumor might respond to the treatments given in the study. Each of the study drugs has been tested individually in humans in clinical trials. To date, giving GVAX pancreas vaccine and CRS-207 together has been studied in one clinical trial.
Ages Eligible for Study: 18 years and above, Genders Eligible for Study: BothInclusion Criteria (abbreviated):1. Documented cancer of the pancreas who have received or refused at least one chemotherapy regimen2. ECOG Performance Status of 0 to 13. Adequate organ function as defined by study-specified laboratory tests4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug5. Signed informed consent form6. Willing and able to comply with study proceduresExclusion criteria (abbreviated):1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions2. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 by the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Systemically active steroids4. Another investigational product within 28 days prior to receiving study drug5. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug6. Infection with HIV, hepatitis B or C at screening7. Pregnant or lactating8. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures9. Have a known allergy to both penicillin and sulfa
This study will randomly assign patients to one of 3 treatment groups in order to determine if one treatment regimen is better than the other. Eighty patients will be assigned to each group and there is an equal chance of being assigned to any of the three treatment groups. The three treatment groups are: A. Cyclophosphamide/ GVAX pancreas vaccine and CRS-207 (2 doses cyclophosphamide and GVAX pancreas vaccine, 3 weeks apart followed by 4 doses of CRS-207, 3 weeks apart)B. CRS-207 (6 doses of CRS-207, 3 weeks apart)C. Doctor's choice of one chemotherapy (Choice of either gemcitabine, irinotecan, 5-fluorouracil (5-FU), erlotinib or capecitabine)
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