Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 8/1/2018 |
| Start Date: | July 19, 2018 |
| End Date: | June 30, 2021 |
| Contact: | Stefania Chirita |
| Email: | schirita@stanford.edu |
| Phone: | 650-723-1423 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Natalie Lui
Phone: 650-723-1423
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