Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
4 other identifiers
interventional
46
1 country
1
Brief Summary
The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedStudy Start
First participant enrolled
May 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedFebruary 9, 2026
February 1, 2026
8 years
April 12, 2018
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably, or possibly related to the study treatment, graded according to Common Terminology Criteria for Adverse Effects (CTCAE) v. 4.0
Descriptive statistical analysis of subject disposition, baseline characteristics, exposure to study drug, and adverse events will be performed. Descriptive statistics for continuous data will include mean, standard deviation, median, minimum, maximum, and inter-quartile values. Frequencies and percentages will be used to summarize categorical data.
Up to 30 days
Secondary Outcomes (3)
Tumor to background ratio (TBR)
30 days from study treatment
Panitumumab Loading Dose
30 days
Optimal Timing of Surgical Procedure
1 year
Study Arms (4)
Cohort 1 -50mg panitumumab-IRDye800
EXPERIMENTALA panitumumab-IRDye800 dose of 50mg (Cohort 1) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.
Cohort 2 -100mg panitumumab-IRDye800
EXPERIMENTALA panitumumab-IRDye800 dose of 100mg (Cohort 2) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.
Cohort 3 -100mg panitumumab-IRDye800
EXPERIMENTALCohort 3 dose will be determined based on Cohort 1 and Cohort 2, with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery
Cohort 4
EXPERIMENTALCohort 4 will enroll 24 participants with vestibular schwannomas at the optimal dose of 100mg, as determined by the research team based on data analysis from the first two cohorts.
Interventions
Given IV
Given IV
Intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during surgery and/or on ex-vivo resected tissues in the surgery suite ("back table").
Undergo NIR imaging
Eligibility Criteria
You may qualify if:
- \) One of the following:
- Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
- Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma
- ) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and/or participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.
- \) Participant age ≥ 18 years.
- \) Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
You may not qualify if:
- Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment.
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding.
- Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
- Any of the following lab values:
- Platelet count \< 75,000/mm3
- TSH ≥ 13 micro International Units/mL.
- Magnesium, potassium, or calcium \< each respective upper limit of normal
- Serum creatinine \> 1.5 times upper limit of normal
- Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Participants not deemed by PI to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Stanford University School of Medicine
Palo Alto, California, 94304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon Li, MD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2018
First Posted
April 27, 2018
Study Start
May 16, 2018
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share