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

NCT ID: NCT02855086

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2016-11-22

Brief 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.

Detailed 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.

Conditions

Brain Neoplasm; Malignant Glioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

50 mg cetuximab-IRDye 800

Patients receive cetuximab IV over 30 minutes and a lower 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 to 5.

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: BIOLOGICAL

Administered intravenously (IV)

Cetuximab-IRDye 800CW

Intervention Type: DRUG

Administered intravenously (IV)

Tumor resection

Intervention Type: PROCEDURE

Standard of care treatment

100 mg cetuximab-IRDye 800

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 to 5.

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: BIOLOGICAL

Administered intravenously (IV)

Cetuximab-IRDye 800CW

Intervention Type: DRUG

Administered intravenously (IV)

Tumor resection

Intervention Type: PROCEDURE

Standard of care treatment

Interventions

Cetuximab

Administered intravenously (IV)

Intervention Type: BIOLOGICAL

Cetuximab-IRDye 800CW

Administered intravenously (IV)

Intervention Type: DRUG

Tumor resection

Standard of care treatment

Intervention Type: PROCEDURE

Other Intervention Names

Erbitux; Chimeric Anti-epidermal growth factor receptor (EGFR0 monoclonal antibody; Chimeric Monoclonal Antibody (MoAb) C225; IMC-C225; Cetuximab-IRDye 800; Cetuximab-IRDye800; Cetuximab-IRDye800CW; Conventional Surgery

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eben Rosenthal

OTHER

Sponsor Role: lead

Responsible Party

Eben Rosenthal

Professor of Otolaryngology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gordon Li, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Eben Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Countries

United States

Other Identifiers

NCI-2016-01165

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRNCNS0008

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA124435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-37595

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-37595

Identifier Type: -

Identifier Source: org_study_id