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| Sponsor: | Ludwig Institute for Cancer Research |
|---|---|
| Collaborator: |
Memorial Sloan-Kettering Cancer Center |
| Information provided by: | Ludwig Institute for Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00199862 |
Purpose
The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Colorectal Cancer Colorectal Tumor Colorectal Carcinoma |
Drug: Iodine-124 labeled humanized A33 (antibody) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Pilot Study of Radioimmunodetection of 124-Iodine-Labeled Humanized A33 Antibody (124I-huA33) in Patients With Colorectal Cancer |
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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), and in the subset of patients scheduled for surgery, based on clinical indications, ex vivo quantitation of tumor uptake will also be performed. Patients will receive a single intravenous or intraarterial infusion of 4 mCi-10mCi /10mg 124I-huA33 in 5-30ml of 5% human serum albumin (HSA), over 5-10 minutes. Patient will either receive the 124I-huA33 intravenously (IV) or intraarterially (IA) to determine if there is an advantage of the IV vs the IA route. Following injection with 124I-huA33, on study days 2, 3, and/ or 4, patients will have the option to receive up to 2g/1kg of Immune Globulin (IVIG).
Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes after completion of IV or IA infusion, on day 2, 3, and/ or 4, and before and after the PET scan on the day of surgery or last imaging day (day 8 + 3). Patients scheduled for surgery will undergo a PET scan of the abdomen and pelvis 1-6 hours prior to surgery.
In those patients undergoing surgery, surgery (or biopsy) will be scheduled to occur day 8 (± 3 days) days after administration of 124I-huA33. Biopsy sites may include tumor, tumor bed, regional nodes, portal, suprapancreatic, celiac nodes and the retroperitoneum. Tumor and normal tissue obtained at surgery (or biopsy), and serum will be measured for estimation of percent-injected dose per gram of tumor, normal liver, and serum. Tissue samples will be obtained for autoradiography and immunohistochemistry as an additional assessment of tumor targeting.
Blood samples to determine immunogenicity will be taken at baseline and at 4 weeks.
Toxicity assessments will be made throughout the study period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christina E Hong | 212- 639-7246 | hongc@mskcc.org |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Steven M Larson, MD 212-639-7373 | |
| Principal Investigator: Steven M Larson, MD | |
| Principal Investigator: Douglas Wong, MD | |
| Principal Investigator: | Steven M Larson, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Ludwig Institute for Cancer Research ( Ralph Venhaus, M.D. ) |
| Study ID Numbers: | LUD2001-011 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00199862 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
huA33 antibody colorectal cancer Iodine 124 124I |
|
Anti-Infective Agents Immunologic Factors Gastrointestinal Diseases Colonic Diseases Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Therapeutic Uses Iodine Micronutrients Immunoglobulins Digestive System Neoplasms Neoplasms by Histologic Type |
Growth Substances Trace Elements Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Carcinoma Anti-Infective Agents, Local Neoplasms Antibodies Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |