Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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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

Study Design

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Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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enzyme-linked immunosorbent assay

Intervention Type OTHER

pharmacological study

Intervention Type OTHER

whole-body scintigraphy

Intervention Type PROCEDURE

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Garden State Cancer Center and Center for Molecular Medicine and Immunology

Principal Investigators

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Aiwu R. He, MD

Role: PRINCIPAL_INVESTIGATOR

Lombardi Comprehensive Cancer Center

Locations

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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Office - Lombardi Comprehensive Cancer Center

Role: primary

Other Identifiers

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CMMI-C-071A-07

Identifier Type: -

Identifier Source: secondary_id

CDR0000636332