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. This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
42
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Safety as Measured by the Number of Participants Who Experienced Toxicity
Participants will be evaluated for toxicity using CTCAE v4.0
Time frame: 2 years
Feasibility of Antibody-imaging
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.
Time frame: 2 years
Biologic Half-time
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 Human anti-human antibody/HAHA if altered biodistribution is observed.
Time frame: Up to 580 hours
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