Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT03510208
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Brain Neoplasm
  • Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Near-Infrared Fluorescence Imaging — PROCEDURE
    Undergo NIR imaging
  • Panitumumab — BIOLOGICAL
    Given IV
  • Panitumumab-IRDye800 — DRUG
    Given IV
  • POINPOINT-IR9000 — DEVICE
    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").

Study Details

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.

Key Dates

Start date
May 16, 2018
Status verified
Feb 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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
  • Experimental: 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.

Primary Outcome Measure

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 [ Time Frame: Up to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicinePalo AltoCalifornia94304
Sandra Torres
[email protected]
650-723-5281
Gordon Li, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University School of Medicine· Palo Alto, CA

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