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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
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Inclusion criteria
Exclusion criteria
Inability to lie still for the duration of the scanning procedure.
Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
Patients who have received trastuzumab must have at least a washout period for trastuzumab of 14 days, this will not apply to 89Zr-DFO-trastuzumab repeat, post treatment assessment where patients may be receiving trastuzumab.
HIV positive or active hepatitis.
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to study entry
Hematologic
Hepatic laboratory values
Renal laboratory values
Primary purpose
Allocation
Interventional model
Masking
36 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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