DNA Methyltransferase Inhibitor SGI-110, Donor GVAX and Cyclophosphamide in Treating Patients with Metastatic Colorectal Cancer

Inclusion Criteria

• Have histologically proven adenocarcinoma of the colon or rectum
• Metastatic colorectal cancer patients * Patient must have received a minimum of 1 systemic therapy in the metastatic setting
• Patients must have at least one lesion which can be biopsied with acceptable clinical risk as judged by the clinical services who perform the biopsy
• Patients must agree to have a biopsy at baseline and on treatment
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy of greater than 4 months
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Lymphocytes >= 500/mcL
• Platelets >= 90,000/mcL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal < 5 x upper limit of normal (ULN) if patient has liver metastases
• Creatinine =< 1.5 x institutional upper limit of normal or creatinine clearance >= 50 mL/min/1.73 m^2
• Total bilirubin =< 1.5 x ULN (patient with diagnosed Gilbert’s syndrome and normal direct bilirubin will be allowed)
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Male patients must agree to use an adequate method of contraception prior to study entry and for the duration of study participation as well
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patient with a known history or evidence of brain metastases
• Patient who has had prior treatment with demethylating agents
• Patient who has had chemotherapy, radiation, hormonal, or biological cancer therapy < 4 weeks prior to the first dose of study drug
• Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 28 days of the first dose of study drug
• Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study
• Patients who have had surgery within 4 weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement
• Patients with a known or suspected hypersensitivity to GM-CSF (sargramostim), Cytoxan, pentastarch or hetastarch, corn, or dimethyl sulfoxide (DMSO)
• Patients who have received any of the following concomitant therapy: interleukin (IL)-2, interferon or other non-study immunotherapy regimens; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses) within 28 days prior to first dose
• Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 28 days of study drug administration; use of such agents while on study is also prohibited
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis); history of Grave’s disease on stable thyroid hormone replacement for at least 1 year is allowed
• Patients with a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
• Women who are pregnant or breastfeeding
• Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential (WOCBP)
• Patients is unwilling or unable to comply with study procedures