Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
NCT ID: NCT03510208
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2018-05-16
2025-12-31
Brief Summary
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Detailed Description
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I. Determine/verify the safety and pharmacokinetic profile of panitumumab conjugated to the optical dye IRDye800CW (panitumumab-IRDye800), as an imaging agent in patients undergoing surgery for malignant glioma.
SECONDARY OBJECTIVES:
I. Determine the efficacy of panitumumab IRDye800 in identifying malignant glioma compared to surrounding normal central nervous system tissue.
II. Determine whether a loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio.
III. Determine the optimal timing of the surgical procedure to maximize the tumor-to-background ratio.
OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1 -50mg panitumumab-IRDye800
A 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.
Near-Infrared Fluorescence Imaging
Undergo NIR imaging
Panitumumab
Given IV
Panitumumab-IRDye800
Given IV
POINPOINT-IR9000
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").
Cohort 2 -100mg panitumumab-IRDye800
A 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.
Near-Infrared Fluorescence Imaging
Undergo NIR imaging
Panitumumab
Given IV
Panitumumab-IRDye800
Given IV
POINPOINT-IR9000
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").
Cohort 3 -100mg panitumumab-IRDye800
Cohort 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
Near-Infrared Fluorescence Imaging
Undergo NIR imaging
Panitumumab
Given IV
Panitumumab-IRDye800
Given IV
POINPOINT-IR9000
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").
Cohort 4
Cohort 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.
Near-Infrared Fluorescence Imaging
Undergo NIR imaging
Panitumumab
Given IV
Panitumumab-IRDye800
Given IV
POINPOINT-IR9000
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").
Interventions
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Near-Infrared Fluorescence Imaging
Undergo NIR imaging
Panitumumab
Given IV
Panitumumab-IRDye800
Given IV
POINPOINT-IR9000
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").
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma
2.) 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.
3\) Participant age ≥ 18 years.
4\) 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.
Exclusion Criteria
2. 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.
3. History of infusion reactions to monoclonal antibody therapies
4. Pregnant or breastfeeding.
5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
6. Any of the following lab values:
1. Platelet count \< 75,000/mm3
2. TSH ≥ 13 micro International Units/mL.
3. Magnesium, potassium, or calcium \< each respective upper limit of normal
4. Serum creatinine \> 1.5 times upper limit of normal
7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. 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.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
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Principal Investigators
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Gordon Li, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2018-00536
Identifier Type: REGISTRY
Identifier Source: secondary_id
BRNCNS0009
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-43179
Identifier Type: -
Identifier Source: org_study_id
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