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

Malignant Glioma Clinical Trial

Official title:

Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02855086
• Other study ID #: IRB-37595
• Secondary ID: NCI-2016-01165BR
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 2016
• Est. completion date: November 22, 2016

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 22, 2016
• Est. primary completion date: November 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasm
• Brain Neoplasms
• Glioma
• Malignant Glioma
• Neoplasms

Intervention

Biological:
• Cetuximab
Administered intravenously (IV)

Drug:
• Cetuximab-IRDye 800CW
Administered intravenously (IV)

Procedure:
• Tumor resection
Standard of care treatment

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Eben Rosenthal	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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.	Up to 30 days