Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer

A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer

The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide

Inclusion Criteria:

• Documented metastatic colorectal cancer
• ECOG Performance Status of 0 to 1
• Adequate organ function as defined by study-specified laboratory tests
• Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
• Signed informed consent form
• Life expectance > 12 weeks

Exclusion Criteria:

• Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, or other medical conditions
• Systemically active steroid use
• Another investigational product within 28 days prior to receiving study drug
• Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
• Chemotherapy, radiation, or biological cancer therapy within 28 days prior to receiving study drug
• No known history or evidence of CNS metastases < 2 years.
• Pregnant or lactating
• Unwilling or unable to comply with study procedures