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

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ClinicalTrials.gov Identifier: NCT02855086
Recruitment Status : Terminated (logistics)
First Posted : August 4, 2016
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

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.

Condition or disease Intervention/treatment Phase
Brain Neoplasm Malignant Glioma Biological: Cetuximab Drug: Cetuximab-IRDye 800CW Procedure: Tumor resection Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 8, 2016
Actual Study Completion Date : November 22, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: 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.

Biological: Cetuximab
Administered intravenously (IV)
Other Names:
  • Erbitux
  • Chimeric Anti-epidermal growth factor receptor (EGFR0 monoclonal antibody
  • Chimeric Monoclonal Antibody (MoAb) C225
  • IMC-C225

Drug: Cetuximab-IRDye 800CW
Administered intravenously (IV)
Other Names:
  • Cetuximab-IRDye 800
  • Cetuximab-IRDye800
  • Cetuximab-IRDye800CW

Procedure: Tumor resection
Standard of care treatment
Other Name: Conventional Surgery

Experimental: 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.

Biological: Cetuximab
Administered intravenously (IV)
Other Names:
  • Erbitux
  • Chimeric Anti-epidermal growth factor receptor (EGFR0 monoclonal antibody
  • Chimeric Monoclonal Antibody (MoAb) C225
  • IMC-C225

Drug: Cetuximab-IRDye 800CW
Administered intravenously (IV)
Other Names:
  • Cetuximab-IRDye 800
  • Cetuximab-IRDye800
  • Cetuximab-IRDye800CW

Procedure: Tumor resection
Standard of care treatment
Other Name: Conventional Surgery




Primary Outcome Measures :
  1. Tumor to Background Ratio (TBR) [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Up to 30 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855086


Locations
United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Eben Rosenthal
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gordon Li, MD Stanford University
Principal Investigator: Eben Rosenthal, MD Stanford University

Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT02855086     History of Changes
Other Study ID Numbers: IRB-37595
NCI-2016-01165 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRNCNS0008 ( Other Identifier: Stanford Cancer Institute )
P30CA124435 ( U.S. NIH Grant/Contract )
IRB-37595 ( Other Identifier: Stanford IRB )
First Posted: August 4, 2016    Key Record Dates
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Cetuximab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents