Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | October 2016 |
| End Date: | November 22, 2016 |
Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
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.
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.
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.
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.
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
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Gordon Li
Phone: 650-721-6509
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