Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery

Stopped early · Phase 1/Phase 2

Conditions studied: Brain Neoplasm, Malignant Glioma

In brief

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.

Key facts

Study ID

NCT02855086

Run by

Eben Rosenthal

People needed

3

Starts

2016-10-01

Expected to finish

2016-11-22

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University, School of Medicine — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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