Clinical trial NCT03582124: Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Tumor to background ratio (TBR), measured in ex vivo tissues
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug
timeFrame: Up to 30 days
measure: Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
timeFrame: Up to 1 year
measure: Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
timeFrame: Up to 1 year
measure: Residual disease detection by Panitumumab-IRDye800 versus standard assessments
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Natalie Lui
role: PRINCIPAL_INVESTIGATOR
References: