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

E

Eben Rosenthal

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Brain Neoplasm
Malignant Glioma

Treatments

Biological: Cetuximab
Procedure: Tumor resection
Drug: Cetuximab-IRDye 800CW

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02855086
P30CA124435 (U.S. NIH Grant/Contract)
NCI-2016-01165 (Registry Identifier)
IRB-37595 (Other Identifier)
BRNCNS0008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3 participants in 2 patient groups

50 mg cetuximab-IRDye 800
Experimental group
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.
Treatment:
Drug: Cetuximab-IRDye 800CW
Procedure: Tumor resection
Biological: Cetuximab
100 mg cetuximab-IRDye 800
Experimental group
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.
Treatment:
Drug: Cetuximab-IRDye 800CW
Procedure: Tumor resection
Biological: Cetuximab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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