Clinical trial NCT02855086: Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
Official title: Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Brain Neoplasm
Malignant Glioma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-08-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.

Detailed description: This is a dose-escalation study of cetuximab-IRDye 800CW. Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients receive cetuximab intravenously (IV) over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

COHORT II: Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.

All patients undergo standard of care surgical resection of tumor on days 2-5.

After completion of study, patients are followed up at days 10 and 30.

PRIMARY OBJECTIVE:

Determine the efficacy of cetuximab-IRDye 800CW (cetuximab IRDye800) in intraoperatively identifying malignant glioma compared to surrounding normal central nervous system tissue, as measured by tumor-to-background ratio.

SECONDARY OBJECTIVE:

Determine the tolerability of the cetuximab IRDye800 as an imaging agent in subjects undergoing resection of malignant glioma.

Eligibility criteria: INCLUSION CRITERIA

* Suspected brain tumors to undergo removal (surgical resection) as standard of care, as assessed by the operating surgeon
* Life expectancy of \> 12 weeks
* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1
* Hemoglobin ≥ 9 gm/dL
* Platelet count ≥ 100,000/mm³
* Magnesium, potassium and calcium \> the lower limit of normal per institution normal lab values
* Thyroid-stimulating hormone (TSH) \< 13 micro international units/mL

EXCLUSION CRITERIA

* Received an investigational drug within 30 days prior to first dose of cetuximab IRDye800
* Within 6 months prior to enrollment, myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina
* History of infusion reactions to cetuximab or other monoclonal antibody therapies
* Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
* Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Pregnant or breastfeeding

Primary outcomes:
measure: Tumor to Background Ratio (TBR)
timeFrame: 1 day
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Gordon Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Eben Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: