Pilot Study Evaluating An Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX) and Low Dose Cyclophosphamide Integrated with Fractionated Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX chemotherapy in Patients with Resected Adenocarcinoma of the Pancreas
This clinical investigation aims to estimate the safety of a whole cell vaccine (allogeneic GM-CSF vaccine, GVAX) with immune modulating doses of cyclophosphamide, SBRT, and FOLFIRINOX chemotherapy.
Inclusion Criteria (abbreviated):1. Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been completely resected2. No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer3. Must be within 10 weeks from surgical resection of cancer4. ECOG Performance Status of 0 to 15. Adequate organ function as defined by study-specified laboratory tests6. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug7. Signed informed consent form8. 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. Presence of metastatic disease3. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.04. Systemically active steroids5. Chemotherapy, radiation therapy or biologic therapy within 28 days prior to receiving study drug6. Inability to begin protocol treatment within 70 days (10 weeks) after surgery to remove cancer7. History of HIV, hepatitis B or C infection8. Pregnant or lactating9. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
This study will give patients immunotherapy before and after concentrated radiation and chemotherapy as adjuvant therapy (following surgery of the pancreas) in pancreatic cancer. Immunotherapy is a type of treatment for cancer based on the idea that the immune system (the system in the body that fights infection) can be activated to destroy cancer cells that have grown undetected. A vaccine is a way of delivering a cancer antigen (something that stimulates the immune system to recognize the cancer) to the immune system so that it recognizes the antigen as foreign and destroys any cells bearing that antigen. This research is being done to see if our experimental pancreatic cancer vaccine can safely be given in combination with concentrated radiation and chemotherapy in the adjuvant setting, and to determine if this regimen will improve upon current therapy and prevent both local and distant spread of pancreas cancer.
06/20/2013 04:02 AM