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RecruitingPhase 1Phase 2NCT03582124

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

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

Sponsor

Stanford University

Enrollment

30 participants

Start Date

Jul 19, 2018

Study Type

INTERVENTIONAL

Conditions

Lung CarcinomaStage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8Metastatic Malignant Neoplasm in the Lung

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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

Interventions

PROCEDURENear-Infrared Fluorescence Imaging

Undergo imaging

DRUGPanitumumab-IRDye800

Given IV

OTHERPharmacokinetic Study

Correlative studies

PROCEDURETherapeutic Conventional Surgery

Undergo surgery

Locations(1)

Stanford University, School of Medicine

Palo Alto, California, United States

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NCT03582124

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