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Panitumumab-IRDye800 for Brain Tumor

Phase 1 & 2
Waitlist Available
Led By Gerald Grant, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject age 6 months to 25 years
Planned standard of care surgery
Must not have
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a dye called panitumumab-IRDye800 is safe to use in children during brain surgery to remove suspected tumors.

Who is the study for?
This trial is for children and young adults aged 6 months to 25 years with suspected brain tumors who are undergoing surgery. They should have a life expectancy over 12 weeks and be fit for tumor removal as per the surgeon's assessment. Pregnant or breastfeeding individuals, those with certain heart risks, abnormal lab values, recent investigational drug use, severe liver disease, or history of bad reactions to monoclonal antibodies cannot join.
What is being tested?
The study tests the safety of Panitumumab-IRDye800 during pediatric brain surgeries. This involves using special devices like Pinpoint-IR9000 and Explorer Air cameras to detect tumors in real-time during operations.
What are the potential side effects?
Potential side effects may include allergic reactions similar to other monoclonal antibody therapies. Since this is a safety assessment trial, detailed side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 months and 25 years old.
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I am scheduled for a standard surgery recommended by my doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had interstitial pneumonitis or pulmonary fibrosis.
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I haven't had a heart attack, stroke, severe heart failure, liver disease, or unstable chest pain in the last 6 months.
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I am taking specific medications for heart rhythm problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Toxicities (related adverse events)
Secondary study objectives
Panitumumab-IRDye800 Fluorescence Intensity
Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4-1.0 Panitumumab-IRDye800Experimental Treatment4 Interventions
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
Group II: Cohort 3-0.50 Panitumumab-IRDye800Experimental Treatment4 Interventions
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
Group III: Cohort 2-0.25 Panitumumab-IRDye800Experimental Treatment4 Interventions
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
Group IV: Cohort 1-0.006 Panitumumab-IRDye800Experimental Treatment4 Interventions
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Explorer Air camera
2019
Completed Phase 1
~20
Panitumumab-IRDye800
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,200 Total Patients Enrolled
Gerald Grant, MDPrincipal InvestigatorStanford University

Media Library

Panitumumab-IRDye800 Clinical Trial Eligibility Overview. Trial Name: NCT04085887 — Phase 1 & 2
Brain Tumor Research Study Groups: Cohort 2-0.25 Panitumumab-IRDye800, Cohort 3-0.50 Panitumumab-IRDye800, Cohort 4-1.0 Panitumumab-IRDye800, Cohort 1-0.006 Panitumumab-IRDye800
Brain Tumor Clinical Trial 2023: Panitumumab-IRDye800 Highlights & Side Effects. Trial Name: NCT04085887 — Phase 1 & 2
Panitumumab-IRDye800 2023 Treatment Timeline for Medical Study. Trial Name: NCT04085887 — Phase 1 & 2
~7 spots leftby Dec 2025
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