Colon Cancer Clinical Trial

Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00895323

Recruitment Status:

Unknown status

Sponsor:

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

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There is 1 Location for this study

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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States More Info
Clinical Trials Office - Lombardi Comprehensive Cancer Center
Contact
202-444-0381

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

9

Study ID:

NCT00895323

Recruitment Status:

Unknown status

Sponsor:


Garden State Cancer Center at the Center for Molecular Medicine and Immunology

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