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

Phase 2TerminatedNCT02855086

Eben Rosenthal3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Brain Neoplasm Malignant Glioma

Interventions

CetuximabBIOLOGICAL

Administered intravenously (IV)

Cetuximab-IRDye 800CWDRUG

Administered intravenously (IV)

Tumor resectionPROCEDURE

Standard of care treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University, School of Medicine

Palo Alto, California, United States

Outcomes

Primary Outcomes

Tumor to Background Ratio (TBR)

Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.

Time frame: 1 day

Secondary Outcomes

Incidence of Adverse Events

The incidence of serious and non-serious adverse events is reported as the number of adverse events (Grade 2 or higher), as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Data are reported by number of events by treatment level.

Time frame: Up to 30 days

Data from ClinicalTrials.gov

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