Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Garden State Cancer Center at the Center for Molecular Medicine and Immunology9 enrolled

Overview

RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease. PURPOSE: This phase I trial is studying how well a bispecific antibody works 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.

Study Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

enzyme-linked immunosorbent assayOTHER

pharmacological studyOTHER

whole-body scintigraphyPROCEDURE

iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

RECRUITING

Outcomes

Primary Outcomes

Pharmacokinetics

Tissue distribution

Data from ClinicalTrials.gov

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