Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

OBJECTIVES:

- Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific
monoclonal antibody TF2 in patients with colorectal cancer.

OUTLINE: This is a multicenter study.

Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2
(^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external
scintigraphy at various times during the study.

Blood samples are collected at baseline and periodically after ^131I-TF2 infusion for
pharmacokinetic studies and ^131I-TF2 biodistribution by ELISA and radioactivity
measurements.

DISEASE CHARACTERISTICS:

- Histologically confirmed colorectal cancer

- Radiological documentation of disease is preferred, but not required

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Life expectancy ≥ 3 months

- WBC ≥ 3,000/mm³

- Neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Serum creatinine normal

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST/ALT < 2 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 1 month after
completion of study therapy

- No medical conditions that might prevent full participation in protocol-required
testing or follow-up

- No institutionalized patients (e.g., in prisons or mental health institutions)

PRIOR CONCURRENT THERAPY:

- No concurrent chemotherapy or treatments that would compromise the safety and
efficacy of protocol assessments