Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
25

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

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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