Washington, District of Columbia 20007

  • Colorectal Cancer

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00895323


Primary Contact:

Principal Investigator
Aiwu R. He, MD
Lombardi Cancer Research Center


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20007
United States

Clinical Trials Office - Lombardi Comprehensive Cancer Center
Phone: 202-444-0381

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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