Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer

NCT00199862 | Completed

• 1 other identifier: 03-124
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Neoplasms; Colorectal Cancer; Colorectal Tumor; COlorectal Carcinoma

Keywords

huA33; antibody; colorectal cancer; Iodine 124; 124I; 03-124

Outcome Measures

Primary Outcomes (5)

• To determine and quantify tumor uptake of radiolabeled antibody from measurements with:

  Until end of study

• PET imaging/Dosimetry

  Until end of study

• Autoradiographs - tumor or biopsy samples

  Until end of study

• Ex vivo radioactivity estimates - tumor, normal tissue and serum samples

  Until end of study

• Toxicity defined by NCI Common Toxicity Criteria

  Until end of study

Secondary Outcomes (2)

• Serum radioactivity, volume of distribution, and half-life following IV and IA 124I-huA33

  Until end of study

• HAHA levels - measured by plasmon resonance surface (Biacore®) assay

  Until end of study

Study Arms (1)

Radio-labeled huA33 Antibody

EXPERIMENTAL

Patients will receive a single I-V infusion of 4mCi-10mCi/10mg 124I-huA33 in 5-30 mL of 5% human serum albumin (HAS) in normal saline, over 5 minutes-4 hours. Patients will be studied with 124I-huA33 positron-emission tomography (PET) and ex-vivo quantitation of tumor uptake . Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes after completion of IV, on and before or after PET scanning on subsequent days. Surgery (or biopsy) will be scheduled to occur 8- 10 days after administration of 124I-huA33. The 8-10 day imaging session will be scheduled for the morning of surgery or biopsy, approximately 1-6 hours before the procedure.

Drug: Iodine-124 labeled humanized A33 (antibody)

Interventions

Iodine-124 labeled humanized A33 (antibody) DRUG

Patients will receive a single intravenous or intraarterial infusion of 10mg huA33, labeled with 4mCi-10mCi of 124I in 5-30ml of 5% HSA in normal saline (NS), over 5-10 minutes. On study days 2, 3, and/or 4 patients will have the option to receive up to 2g/kg of IVIG. Patients will be evaluated with 124I-huA33 positron-emission tomography (PET) with ex vivo quantitation of tumor uptake.

Radio-labeled huA33 Antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Ludwig Institute for Cancer Research: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Antibodies

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Neeta Pandit-Taskar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2004
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)