PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer

Esophagogastric Cancer Clinical Trial

Official title:

Pilot Trial of PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023996
• Other study ID #: 13-165
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: June 27, 2023

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Registered patient at MSKCC
• Age =18 years
• Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer HER2 positive status by FISH or IHC as currently being implemented for patients with esophagogastric cancer. HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (=2.0)
• Measurable or evaluable disease, lesions that have not been previously radiated, with clinically indicated imaging evaluation performed within 4 weeks prior to study entry (CT, MRI, FDG PET or bone scan). Patients requiring concurrent radiation treatment are not eligible unless additional lesions that are not being irradiated and are assessable for targeting are present.
• Karnofsky Performance Score = 60
• Ability to understand and willingness to sign informed consent
• Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
• Life expectancy of at least three (3) months.
• Willingness to use birth control while on study.
• The patients will be asked to consent to provide access to data obtained from molecular analysis that has been done on archived tumor tissue that will be correlated with 89Zr-DFO-trastuzumab imaging results.
• Concurrent therapy will be allowed.

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
• Platelets <50K/mcL
• ANC <1.0 K/mcL
• Hepatic laboratory values
• Bilirubin >2 x ULN (institutional upper limits of normal), with exception of patients with Gilberts disease. AST/ALT >2.5 x ULN (institutional upper limits of normal); >5 x ULN if liver metastasis
• Renal laboratory values
• Estimated GFR (eGFR) < 30mL/min/1.73m2

Related Conditions & MeSH terms

• Esophagogastric Cancer

Intervention

Radiation:
• 89Zr-DFO-trastuzumab

Device:
• PET imaging

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity	(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.	2 years
Primary	feasibility	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.	2 years
Secondary	metabolite analysis	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center