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NCT00199862Completed

Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer

A Pilot Study of Radioimmunodetection of 124-Iodine-labeled Humanized A33 Antibody (124I-huA33) in Patients With Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 4 Jul 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
30 (estimated)
First submitted
13 Sept 2005
Start date
Feb 2004
Primary completion date
2 Jul 2025
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT00199862

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From Feb 2004 to the primary completion date, 2 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active CNS tumor involvement. Previous treatment with A33 or its fragment and/or a positive test for huA33 HAHA.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.

Other illness

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

Other

  • Lack of availability for immunological and clinical follow-up assessments.
  • Women who are pregnant or breast-feeding.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.