RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver
tumor-killing substances to them without harming normal cells. This may be an effective
treatment for gastrointestinal cancer.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody
therapy in treating patients who have gastrointestinal cancer.
OBJECTIVES: I. Determine the biodistribution and biokinetics of iodine I 131-labeled
monoclonal antibody CC49-delta CH2 in patients with gastrointestinal adenocarcinoma. II.
Determine the human anti-human monoclonal antibody response in patients treated with this
OUTLINE: Patients receive iodine I 131-labeled monoclonal antibody CC49-delta CH2 (131I MOAB
CC49-delta CH2) IV over 5-10 minutes on day 0. Patients also receive unlabeled monoclonal
antibody CC49-delta CH2 IV over 5 minutes followed by 131I MOAB CC49-delta CH2 IV over 5-10
minutes on day 28. Patients are followed weekly for 4 months and then every 3 months for 1
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the esophagus,
stomach, pancreas, colon, or rectum More than 30% positively immunoreactive to monoclonal
antibody CC49 in the metastatic or primary lesion OR TAG-72 antigen serum level greater
than 15 Measurable or evaluable unresectable or metastatic disease by CT scan
PATIENT CHARACTERISTICS: Age: 19 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than
150,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL ALT and
AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases
present) PTT less than 37.0 seconds INR less than 2.0 Renal: Creatinine less than 2.0
mg/dL Other: No known allergy to murine immunoglobulin No iodine allergy No concurrent
illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception Must be ambulatory and able to comply with study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine immunoglobulin Chemotherapy:
Prior or concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy:
Prior radiotherapy allowed Surgery: See Disease Characteristics