PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer
This study is divided into two groups. The purpose of the first group (Group 1) was to find the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how long it stayed in the blood, and to see how well it was tolerated. From what the investigators have learned from Group 1, patients in Group 2 no longer need serial scans or serial blood draws.
For Group 2, the patient will receive the injection of 89Zr-DFO-trastuzumab and will be monitored following the injection. The patient will be asked to return for a picture 5-8 days after injection to determine how well the study drug attaches to your tumor and how well it is tolerated
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pilot Trial of PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer|
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ](CTCAE v4) Incidence and nature and severity of adverse events; and change in vital signs and clinical laboratory results. Incidence and severity of adverse events will be summarized with descriptive statistics.
- feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]Antibody imaging is considered feasible if 70% of the patients are antibody-imaging positive. Antibody imaging will be considered feasible if 7 or more of the 10 patients in the first cohort are antibody-imaging-positive.We will also require that none of these patients experience severe toxicity attributable to the initial antibody.
- metabolite analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]Samples will be obtained just prior to injection of the 89Zr DFO-trastuzumab tracer this sample will be banked at -80degree C for future testing for immune response (HAHA) if altered biodistribution is observed., and at 5 ± 2 minutes, 15 ± 5, 30 ± 9, 60 ± 19 minutes, and 120 − 240 minutes after the injection of the tracer 1, and at the time of each subsequent day of imaging.
|Study Start Date:||December 2013|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: PET Imaging With 89Zr-DFO-Trastuzumab
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg . In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics & determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts & blood draws. Subsequent patients will receive the antibody & will only undergo imaging at a single time point (based on the first 10 patients) & will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
|Radiation: 89Zr-DFO-trastuzumab Device: PET imaging|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02023996
|Contact: Wolfgang Weber, MD||212-639-7373|
|Contact: Yelena Janjigian, MD||646-888-4186|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Wolfgang Weber, MD 212-639-7373|
|Contact: Yelena Janjigian, MD 646-888-4186|
|Principal Investigator: Wolfgang Weber, MD|
|Principal Investigator:||Wolfgang Weber, MD||Memorial Sloan Kettering Cancer Center|