Palo Alto, California 94304


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03582124


Primary Contact:

Principal Investigator
Natalie Lui
Stanford University

Stefania Chirita
Phone: 650-723-1423
Email: schirita@stanford.edu


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States

Stefania Chirita
Phone: 650-723-1423
Email: schirita@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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