This pilot clinical trial studies the side effects of zirconium Zr 89 trastuzumab and to see how well it works with positron emission tomography (PET) in detecting tumors in patients with human epidermal growth factor 2 (HER2) positive esophagogastric cancer. Radioactive substances, such as zirconium Zr 89, linked to monoclonal antibodies, such as trastuzumab, can bind to tumor cells and give off radiation which may help kill tumor cells and may help determine HER2 positive tumor cells through PET imaging.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02023996.
PRIMARY OBJECTIVES:
I. Evaluate the safety of zirconium Zr 89 trastuzumab (89Zr-desferroxamine [DFO]-trastuzumab) and ability to detect tumors using PET imaging in patients with HER2 positive esophagogastric (EG) cancer.
II. Determine the biodistribution and pharmacokinetics in normal organs and tumor of 89Zr-DFO-trastuzumab in patients with esophagogastric cancer, and perform dosimetry estimates based on the data.
SECONDARY OBJECTIVES:
I. Evaluate changes in biodistribution of 89Zr-DFO-trastuzumab in patients receiving HER2 directed therapy.
II. Patients who have archived tissue or will be having a clinically indicated biopsy will be asked to consent to have this tissue made available for molecular analysis of their tumor to correlate with imaging results.
III. Evaluate imaging results with response to treatment.
OUTLINE:
Patients receive zirconium Zr 89 trastuzumab intravenously (IV) over 5-10 minutes. The first 10 patients undergo PET imaging 1-4 hours, 24 hours, 48-96 hours, and 120-192 hours post injection and subsequent patients undergo PET imaging at a single optimal time point based on the first 10 patients. Patients receiving standard of care therapies directed at HER2 may receive an optional repeat treatment and imaging 2-6 weeks after the start of the standard of care treatment.
After completion of study treatment, patients will be followed up after 2 weeks.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNeeta Pandit-Taskar