DAB 9405 
March 16, 1994 
PAGE - 9 
4.0 PATIENT SELECTION CRITERIA 
4.1 
4.2 
4.3 
4.4 
4.5 
4.6 
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4.10 
4.11 
4.12 
Patients must have pathologically proven colon or rectal adenocarcinoma with 
documented CEA positive tumor cells having been resistant to or relapsed from at 
least one chemotherapy regimen for metastatic disease. 
A minimum of 30 days should have elapsed from the time of completion of prior 
chemotherapy and/or radiation therapy. 
Recovery from all treatment related toxicity. 
No concurrent chemotherapy, radiotherapy or drugs which affect immune 
function such as glucocorticoids. Immunomodulatory drugs such as Cimetidine 
should not be administered. 
Evidence of metastatic disease by a staging work-up (physician examination, 
chest x-ray and abdominal CT) with objectively measurable tumor masses. Chest 
x-rays or abdominal CT’s performed within 30 days of starting treatment on study 
will be accepted. 
A positive skin test to at least one recall antigen (e.g., mumps, Candida, 
trichophytin) within 30 days prior to enrollment. 
Patients must have the following organ system function: 
Hematopoietic Leukocyte of at least 3,500/mm^; platelet count of at least 
120,000/mm^ 
Renal 
Hepatic 
Cardiac 
BUN <30 mg%; creatinine <2 mg%. 
Bilirubin <1.5 mg%, alkaline phosphatase <3 times normal. 
No evidence of congestive heart failure, unstable angina or 
serious cardiac arrhythmias. 
No prior history of malignancy, except treated basal cell, skin squamous cell 
cancer or carcinoma in situ of the cervix. 
Patients must be >18 yeeirs of age. 
Patients must not be pregnant. Women of child-bearing age must have a negative 
pregnancy test and be on an adequate contraceptive program. 
No serologic evidence of hepatitis B infection. 
Patients must provide written informed consent. 
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Recombinant DNA Research, Volume 19 
