Study of IMMU-130 in Patients With Relapsed/Refractory Colorectal Cancer

Exclusion Criteria

• •Women who are pregnant or lactating.
• •Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
• •Patient's with Gilbert's disease or known CNS Metastatic disease. However, patients with CNS metastases who are asymptomatic and have completed a course of therapy are eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new enlarging CNS metastasis (2) off steroids or on a stable dose of steroids
• •Patients with CEA plasma level \> 1000 ng/mL are excluded during dose escalation, but may be included after the MTD is determined
• •Patients with active grade 3 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
• •Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 3-year disease free interval.
• •Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• •Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy,
• •Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
• •Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids, and other than diabetes, vitiligo, or stable thyroid disease).
• •Infection requiring intravenous antibiotic use within 1 week.
• •Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.