Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect colorectal cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Ludwig Institute for Cancer Research
• Treatments: Antibodies; Immunoglobulins; Iodine

Criteria

Inclusion Criteria:

• Primary or metastatic colorectal carcinoma, histologically confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC).

• Patients must be candidates for clinically indicated surgery/biopsy for primary/metastatic colorectal cancer

• Expected survival of at least 3 months.

• Karnofsky performance status ≥ 70 (ECOG 0 or 1).

• The following laboratory results within the last 2 weeks prior to study day 1:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 75 x 109/L Serum bilirubin ≤ 2.5 mg/dL Serum creatinine ≤ 2.0 mg/dL White Blood Count (WBC) ≥ 3,000/mm3 Age ≥ 18 years. Children of all ages are not included as colon cancer is extremely rare in children.

• Women of childbearing potential with confirmed negative pregnancy test on the day of administration of study agent.

• Before any trial-specific procedures or treatment can be performed, the patient or patient's legally authorized guardian or representative must give witnessed written informed consent for participation in the tria

Exclusion Criteria:

• Clinically significant cardiac disease (New York Heart Association Class III/IV).

• Active CNS tumor involvement. Previous treatment with A33 or its fragment and/or a positive test for huA33 HAHA.

• Lack of availability for immunological and clinical follow-up assessments.

• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.

• Women who are pregnant or breast-feeding.