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Pilot Evaluation of Radioimmunodetection of ¹²⁴Iodine-labeled Humanized A33 Antibody (¹²⁴I-huA33) in Patients with Colorectal Cancer

[Protocol 03-124]

Full Title :

A PILOT EVALUATION OF RADIOIMMUNODETECTION OF 124-IODINE-LABELED HUMANIZED A33 ANTIBODY (124I-HUA33)IN PATIENTS WITH COLORECTAL CANCER

Purpose :

Doctors are seeking ways to improve the accuracy of positron-emitting tomography (PET) scanning for assessing the extent of disease in patients with colon cancer. One possible way to accomplish this goal is by attaching a radioactive substance that can be detected by PET scanning to an antibody that targets colon cancer cells. In this study, investigators are determining the usefulness of a monoclonal antibody called huA33 for diagnosis and for detecting the presence of a protein called the A33 antigen. HuA33, an antibody made in a laboratory, appears to attach itself to colon cancer cells, and may trigger the immune system to kill these cells. Radioactive iodine 124 (¹²⁴I) labeled to A33 can be detected by PET scanning.

The aims of this study are to see: (1) if huA33 attached to ¹²⁴I can be safely given to patients with colorectal cancer, (2) if the radioactivity binds only to cancer cells, and not normal cells, and (3) if the measurement of radioactivity made with the PET scanner is the same as the radioactivity detected when the tumor is surgically removed from the body and counted using a gamma counter. Researchers will determine how well huA33 targets colon cancer cells. Ultimately, if huA33 tagged with ¹²⁴I is safe for patients and targets only cancer cells, this approach may lead to a more accurate way to determine the spread of colon cancer.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of colorectal cancer and be candidates for surgery or biopsy of the cancer.
• Patients who have had previous treatment with A33 or its fragment and/or a positive test for huA33 human antihuman antibody may not participate.
• Patients must not be confined to a bed or chair for more than half of their normal waking hours.
• Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. Steven Larson at 212-639-7373.