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

• Status: Terminated
• Trial end date: 2016-11-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eben Rosenthal
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Cetuximab; Immunoglobulins

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