Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00895323
• Other study ID #: CDR0000636332
• Secondary ID: CMMI-C-071A-07
• Status: Recruiting
• Phase: Phase 1
• First received: May 7, 2009
• Last updated: September 16, 2013
• Start date: November 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• enzyme-linked immunosorbent assay

• pharmacological study

Procedure:
• whole-body scintigraphy

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

Locations

Country	Name	City	State
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics			No
Primary	Tissue distribution			No