Back to resultsPanitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
Primary Purpose
Lung Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage IV Lung Cancer AJCC v8
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Near-Infrared Fluorescence Imaging
Panitumumab-IRDye800
Pharmacokinetic Study
Therapeutic Conventional Surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Carcinoma
Eligibility 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
Sites / Locations
- Stanford University, School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (panitumumab-IRDye800, surgery, NIR)
Arm Description
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
Outcomes
Primary Outcome Measures
Tumor to background ratio (TBR), measured in ex vivo tissues
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
Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug
Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
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.
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
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.
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03582124
Brief Title
Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eben Rosenthal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (panitumumab-IRDye800, surgery, NIR)
Arm Type
Experimental
Arm Description
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
Intervention Type
Procedure
Intervention Name(s)
Near-Infrared Fluorescence Imaging
Other Intervention Name(s)
NIR Fluorescence Imaging, NIR Optical Imaging
Intervention Description
Undergo imaging
Intervention Type
Drug
Intervention Name(s)
Panitumumab-IRDye800
Other Intervention Name(s)
Panitumumab IRDye 800, RDye800-Panitumumab Conjugate
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Pharmacokinetic Study
Other Intervention Name(s)
PHARMACOKINETIC, PK Study
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo surgery
Primary Outcome Measure Information:
Title
Tumor to background ratio (TBR), measured in ex vivo tissues
Description
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).
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
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
Title
Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
Description
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.
Time Frame
Up to 1 year
Title
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
Description
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.
Time Frame
Up to 1 year
Title
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
Description
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.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Lui
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
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Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
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