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Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

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ClinicalTrials.gov Identifier: NCT03582124
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

Brief Summary:
This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.

Condition or disease Intervention/treatment Phase
Lung Carcinoma Metastatic Malignant Neoplasm in the Lung Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Procedure: Near-Infrared Fluorescence Imaging Drug: Panitumumab-IRDye800 Other: Pharmacokinetic Study Procedure: Therapeutic Conventional Surgery Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.

SECONDARY OBJECTIVES:

I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.

II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.

OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.

Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.

After completion of study treatment, participants are followed up for up to 30 days.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Panitumumab

Arm Intervention/treatment
Experimental: Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
Procedure: Near-Infrared Fluorescence Imaging
Undergo imaging
Other Names:
  • NIR Fluorescence Imaging
  • NIR Optical Imaging

Drug: Panitumumab-IRDye800
Given IV
Other Names:
  • Panitumumab IRDye 800
  • RDye800-Panitumumab Conjugate

Other: Pharmacokinetic Study
Correlative studies
Other Names:
  • PHARMACOKINETIC
  • PK Study

Procedure: Therapeutic Conventional Surgery
Undergo surgery




Primary Outcome Measures :
  1. Tumor to background ratio (TBR), measured in ex vivo tissues [ Time Frame: Up to 1 year ]
    The TBR is defined as the near-infrared fluorescence signal of tumor or lymph node tissue compared to normal adjacent tissue measured in ex vivo tissues. Outcomes will be reported as the TBR (mean) and standard deviation for each dose group and timing group (1-2 days or 3-5 days prior to surgery).


Secondary Outcome Measures :
  1. Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug [ Time Frame: Up to 30 days ]
  2. Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments [ Time Frame: Up to 1 year ]
    Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify metastatic lesions. Outcomes will be reported as the number of metastatic lesions detected by both near-infrared fluorescence imaging and histopathology, and each method alone.

  3. Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments [ Time Frame: Up to 1 year ]
    Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify tumor-positive lymph nodes. Outcomes will be reported as the number of tumor-positive lymph nodes detected by both near-infrared fluorescence imaging and histopathology, and each method alone.

  4. Residual disease detection by Panitumumab-IRDye800 versus standard assessments [ Time Frame: Up to 1 year ]
    Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify residual disease at resection margins. Outcomes will be reported as the number of positive-margins detected by both near-infrared fluorescence imaging and histopathology, and each method alone.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
  • Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
  • Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
  • Hemoglobin ≥ 9 gm/dL
  • White blood cell count > 3000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 1.5 times upper reference range

Exclusion Criteria:

  • Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  • History of infusion reactions to monoclonal antibody therapies
  • Pregnant or breastfeeding
  • Magnesium or potassium lower than the normal institutional values
  • Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Prisoners, institutionalized individuals, and patients unable to consent for themselves

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582124


Contacts
Contact: Stefania Chirita 650-723-1423 schirita@stanford.edu

Locations
United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Stefania Chirita    650-723-1423    schirita@stanford.edu   
Principal Investigator: Natalie Lui         
Sponsors and Collaborators
Eben Rosenthal
Investigators
Principal Investigator: Natalie Lui Stanford University

Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT03582124     History of Changes
Other Study ID Numbers: LUN0099
NCI-2018-00494 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
LUN0099 ( Other Identifier: Stanford Cancer Institute Palo Alto )
IRB-41302 ( Other Identifier: Stanford IRB )
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms
Neoplasms, Second Primary
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs