A Pilot Study of SGI-110 in Combination with an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) as Maintenance Therapy
This research is being done to look for an appropriate dose and to test the effectiveness (anti-tumor activity) and safety of the investigational colon cancer vaccine called GVAX either in combination with cyclophosphamide and SGI-110or alone in people with advanced colorectal cancer. We want to see if the vaccine can help your body's immune system recognize and attack your own colorectal cancer cells.
Inclusion Criteria (abbreviated):1. Documented adenocarcinoma of the colon or rectum2. Stable metastatic colorectal cancer after first-line or second-line therapy regimens3. ECOG performance status of 0 or 14. Adequate organ and marrow function defined by study-specified laboratory tests.5. Must agree to use acceptable form of birth control while on studyExclusion Criteria (abbreviated):1. Surgery within 4 weeks of receiving study drug (some exceptions for minor procedures)2. Previously received treatment with demethylating agents.3. Receiving any other investigational agents4. Received chemotherapy, radiation, hormonal, or biological cancer therapy less than 4 weeks.5. History of chronic steroid treatments.6. History of autoimmune disease or immune impairment7. Known brain metastasis8. Uncontrolled intercurrent illness9. Known or suspected hypersensitivity to GM-CSF10. Pregnant or breastfeeding women
This study will be conducted in two stages. During the first stage, up to 20 patients will be randomly assigned to receive SGI-110 either at the same time or before the colon cancer vaccine with cyclophosphamide. If an anti-tumor response is observed in either one of these first 2 treatment groups, then the second stage of the study will open up and up to 12 patients will be randomly assigned to receive either SGI-110 or the colon cancer vaccine with cyclophosphamide. Patients in all treatment groups will be treated in 4, consecutive 28 day cycles. Patients whose disease remains stable after the first four cycles, have the option of continuing the treatments they are receiving in their treatment groups, until their condition worsens or they experience an unacceptable side effect. The scheduling for additional treatments will be SGI-110 every 28 days and the colon cancer vaccine with cyclophosphamide every 6 months.
09/20/2014 04:03 AM