Clinical trial · Interventional
Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
NCT02855086CI-TRIAL-00044363terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): logistics
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasm | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Biological | Cetuximab | ALIAS |
| Cetuximab-IRDye 800CW | Drug | — | UNRESOLVED |
| Tumor resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 50 mg cetuximab-IRDye 800
- 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.
- interventionNames
- Biological: Cetuximab
- Drug: Cetuximab-IRDye 800CW
- Procedure: Tumor resection
- type
- EXPERIMENTAL
- label
- 100 mg cetuximab-IRDye 800
- 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.
- interventionNames
- Biological: Cetuximab
- Drug: Cetuximab-IRDye 800CW
- Procedure: Tumor resection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.