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

May 7, 2009
September 16, 2013
November 2008
March 2010   (final data collection date for primary outcome measure)
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Tissue distribution [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00895323 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Diagnostic
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
Not Provided
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT00895323
CDR0000636332, CMMI-C-071A-07
Not Provided
Sylvia Gargiulo, Garden State Cancer Center and Center for Molecular Medicine and Immunology
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Not Provided
Principal Investigator: Aiwu R. He, MD Lombardi Cancer Research Center
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP