PET with Zirconium Zr 89 Trastuzumab in Detecting Tumors in Patients with HER2 Positive Esophagogastric Cancer

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Registered patient at Memorial Sloan-Kettering Cancer Center (MSKCC)
  • Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer; HER2 positive status by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) as currently being implemented for patients with esophagogastric cancer; HER2 overexpression and/or amplification as determined by IHC (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 (computed tomography [CT], magnetic resonance imaging [MRI], fluorodeoxyglucose [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 1 week 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 desferrioxamine [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
  • Human immunodeficiency virus (HIV) positive or active hepatitis
  • History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry
  • Platelets < 50 K/mcL
  • Absolute neutrophil count (ANC) < 1.0 K/mcL
  • Bilirubin > 2 x institutional upper limits of normal (ULN), with exception of patients with Gilberts disease
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN (institutional upper limits of normal); > 5 x ULN if liver metastasis
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Locations & Contacts

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Neeta Pandit-Taskar
Phone: 212-639-3046

Trial Objectives and Outline

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 Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Neeta Pandit-Taskar

Trial IDs

Primary ID 13-165
Secondary IDs NCI-2016-00986
Clinicaltrials.gov ID NCT02023996