Clinical trial · Interventional
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
NCT00199862CI-TRIAL-00091793completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect colorectal cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| COlorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Tumor | Colorectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iodine-124 labeled humanized A33 (antibody) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radio-labeled huA33 Antibody
- description
- 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.
- interventionNames
- Drug: Iodine-124 labeled humanized A33 (antibody)
Primary outcomes (5)
- measure
- To determine and quantify tumor uptake of radiolabeled antibody from measurements with:
- timeFrame
- Until end of study
- measure
- PET imaging/Dosimetry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.