Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting

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 Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: pharmacological study; Other: enzyme-linked immunosorbent assay; Procedure: whole-body scintigraphy; Radiation: iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2

Detailed Description

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
• Enrollment (Anticipated): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
      • Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center; Phone Number: 202-444-0381

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics
Tissue distribution

Collaborators and Investigators

• Sponsor: Garden State Cancer Center at the Center for Molecular Medicine and Immunology
• Investigators: Principal Investigator: Aiwu R. He, MD, Lombardi Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: May 7, 2009
• First Submitted That Met QC Criteria: May 7, 2009
• First Posted (Estimate): May 8, 2009

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: stage IV rectal cancer; stage IV colon cancer; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer; stage II colon cancer; stage I rectal cancer; stage I colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal; Antibodies, Bispecific
• Other Study ID Numbers: CDR0000636332; CMMI-C-071A-07