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

Not Applicable

Completed

• Conditions: Esophagogastric Cancer
• Interventions: Radiation: 89Zr-DFO-trastuzumab; Device: PET imaging

• Registration Number: NCT02023996
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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. This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Status Verified: 2023-06
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Results First Submitted: 2024-06-26
• Results First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Results First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET Imaging With 89Zr-DFO-Trastuzumab	89Zr-DFO-trastuzumab	Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
PET Imaging With 89Zr-DFO-Trastuzumab	PET imaging	Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.

Primary Outcome Measures

Name	Time	Method
Safety as Measured by the Number of Participants Who Experienced Toxicity	2 years	Participants will be evaluated for toxicity using CTCAE v4.0
Feasibility of Antibody-imaging	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Biologic Half-time	Up to 580 hours	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 Human anti-human antibody/HAHA if altered biodistribution is observed.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States