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

• Status: Active, not recruiting
• Trial end date: 2023-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eben Rosenthal
• Treatments: Antibodies, Monoclonal; Panitumumab

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