Phase II/Pilot Study of 2nd Generation Anti-CEA Designer T Cells in Adenocarcinomas

Inclusion Criteria

• •Patients with histologically confirmed diagnosis of CEA-expressing adenocarcinoma. Patient may have measurable tumor by physical examination or by radiologic studies, and/or evaluable disease, including bone lesions. Soluble CEA is not acceptable as the sole measure of disease, although it may be followed in addition to measurable or other evaluable disease.
• •Tumor must be CEA-expressing as demonstrated by elevated serum CEA levels(\>10 ng/ml). Preference will be given to patients with CEA \>100 ng/mL to increase the sensitivity of CEA as a measure of the tumor response.
• •Where preserved tumor tissue is available, direct immuno¬histochemical staining of tumor is obtained to demonstrate CEA expression on tumor cells.
• •Patient must be at least 18 years of age.
• •Patient able to understand and sign informed consent.
• •Patient with a life expectancy of greater than four months.
• •Patient failed standard potentially curative therapy.
• •Patient with performance status of 0 to 1 (ECOG).
• •Patient with adequate organ function as defined by:
• •* ANC 1.0, platelets 50,000, Hgb 8.0; patient may be transfused to achieve Hgb 8.0 to satisfy enrollment criteria, or as otherwise indicated by symptoms for Hgb \>8.0.
• •* Creatinine 1.5mg/dl or creatinine clearance 60cc/min.
• •* Direct bilirubin 1.5 mg/dl.
• •* No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, including atrial fibrillation/atrial flutter, evidence of prior myocardial infarction by history or by EKG.
• •A normal cardiac stress test for inducible ischemia or arrhythmia within 12 weeks prior to enrollment for all patients over 50 years old or those with abnormal EKG or any history or symptoms suggestive of cardiac disease.