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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02023996
First received: December 18, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to see if a new research agent named 89Zr-DFO-trastuzumab can show esophagogastric cancer tumors on a PET scan. Also to see how long 89Zr-DFO-trastuzumab lasts in the blood when given in small amounts.


Condition Intervention
Esophagogastric Cancer
Radiation: 89Zr-DFO-trastuzumab
Device: PET imaging

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Trial of PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    (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.

  • feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • metabolite analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 25
Study Start Date: December 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET Imaging With 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.
Radiation: 89Zr-DFO-trastuzumab Device: PET imaging

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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 Desferroxiamine (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 If prior experimental therapy has been received a period of washout appropriate to the prior treatment is required (for example 2 weeks for trastuzumab). Patients requiring concurrent radiation treatment will not be recruited unless they have additional lesions that are not being irradiated and are assessable for targeting.
  • Hematologic

    • Platelets <50K/mcL
    • ANC <1.0 K/mcL
  • Hepatic laboratory values

    o 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 o Estimated GFR (eGFR) < 30mL/min/1.73m2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023996

Contacts
Contact: Jorge Carrasquillo, MD 212-639-2459
Contact: Yelena Janjigian, MD 646-888-4186

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jorge Carrasquillo, MD    212-639-2459      
Contact: Yelena Janjigian, MD    646-888-4186      
Principal Investigator: Jorge Carrasquillo, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jorge Carrasquillo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02023996     History of Changes
Other Study ID Numbers: 13-165
Study First Received: December 18, 2013
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
HER2 positive
PET Imaging
89Zr-DFO-trastuzumab
13-165

Additional relevant MeSH terms:
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014