Status:
COMPLETED
Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Ludwig Institute for Cancer Research
Conditions:
Colorectal Neoplasms
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect colorectal cancer.
Detailed Description
This is an open-label, pilot study of a single 4mCi-10mCi/10mg IV dose of 124I-huA33 in patients with colorectal cancer. Patients will be studied with 124I-huA33 positron-emission tomography (PET), an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 2 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00199862
Start Date
February 1 2004
End Date
July 2 2025
Last Update
July 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065