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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Lung Carcinoma
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, School of Medicine, Palo Alto, California, United States, 94304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eben Rosenthal,

Natalie Lui, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2027-02