Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00895323
First received: May 7, 2009
Last updated: September 16, 2013
Last verified: July 2009
  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.


Condition Intervention Phase
Colorectal Cancer
Other: enzyme-linked immunosorbent assay
Other: pharmacological study
Procedure: whole-body scintigraphy
Radiation: iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Tissue distribution [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: November 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895323

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center    202-444-0381      
Sponsors and Collaborators
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Investigators
Principal Investigator: Aiwu R. He, MD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sylvia Gargiulo, Garden State Cancer Center and Center for Molecular Medicine and Immunology
ClinicalTrials.gov Identifier: NCT00895323     History of Changes
Other Study ID Numbers: CDR0000636332, CMMI-C-071A-07
Study First Received: May 7, 2009
Last Updated: September 16, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Antibodies
Antibodies, Bispecific
Antibodies, Monoclonal
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014