Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Study Overview
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: enzyme-linked immunosorbent assay|nan|
|Other: pharmacological study|nan|
|Procedure: whole-body scintigraphy|nan|
|Radiation: iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  | 
| Tissue distribution |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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