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

Primary Purpose

Brain Neoplasm, Malignant Glioma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Cetuximab-IRDye 800CW
Tumor resection
Sponsored by
Eben Rosenthal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

50 mg cetuximab-IRDye 800

100 mg cetuximab-IRDye 800

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 1, 2016
Last Updated
March 17, 2020
Sponsor
Eben Rosenthal
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02855086
Brief Title
Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
Official Title
Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
logistics
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 8, 2016 (Actual)
Study Completion Date
November 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eben Rosenthal
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm, Malignant Glioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 mg cetuximab-IRDye 800
Arm Type
Experimental
Arm Description
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.
Arm Title
100 mg cetuximab-IRDye 800
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux, Chimeric Anti-epidermal growth factor receptor (EGFR0 monoclonal antibody, Chimeric Monoclonal Antibody (MoAb) C225, IMC-C225
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Cetuximab-IRDye 800CW
Other Intervention Name(s)
Cetuximab-IRDye 800, Cetuximab-IRDye800, Cetuximab-IRDye800CW
Intervention Description
Administered intravenously (IV)
Intervention Type
Procedure
Intervention Name(s)
Tumor resection
Other Intervention Name(s)
Conventional Surgery
Intervention Description
Standard of care treatment
Primary Outcome Measure Information:
Title
Tumor to Background Ratio (TBR)
Description
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 Outcome Measure Information:
Title
Incidence of Adverse Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Li, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eben Rosenthal, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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

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