Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
25

Inclusion Criteria

Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
Age ≥18 years
Karnofsky Performance Score ≥ 60
...
Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
Age ≥18 years
Karnofsky Performance Score ≥ 60
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.
Ability to understand and willingness to sign informed consent
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.
Registered patient at MSKCC
Concurrent therapy will be allowed.
Willingness to use birth control while on study.
Life expectancy of at least three (3) months.

Exclusion Criteria

Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
Estimated GFR (eGFR) < 30mL/min/1.73m2
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.
...
Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
Estimated GFR (eGFR) < 30mL/min/1.73m2
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.
Platelets <50K/mcL
Inability to lie still for the duration of the scanning procedure.
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
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
ANC <1.0 K/mcL

Summary

Conditions
Esophagogastric Cancer
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
Age ≥18 years
Karnofsky Performance Score ≥ 60
...
Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
Age ≥18 years
Karnofsky Performance Score ≥ 60
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.
Ability to understand and willingness to sign informed consent
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.
Registered patient at MSKCC
Concurrent therapy will be allowed.
Willingness to use birth control while on study.
Life expectancy of at least three (3) months.

Exclusion Criteria

Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
Estimated GFR (eGFR) < 30mL/min/1.73m2
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.
...
Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
Estimated GFR (eGFR) < 30mL/min/1.73m2
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.
Platelets <50K/mcL
Inability to lie still for the duration of the scanning procedure.
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
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
ANC <1.0 K/mcL

Tracking Information

NCT #
NCT02023996
Collaborators
Not Provided
Investigators
  • Principal Investigator: Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center
  • Neeta Pandit-Taskar, MD Memorial Sloan Kettering Cancer Center
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