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Panitumumab-IRDye800 for Brain Cancer
Phase 1 & 2
Recruiting
Led By Gordon Li
Research Sponsored by Eben Rosenthal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with suspected brain tumors undergoing surgical removal as their standard of care
Be older than 18 years old
Must not have
History of interstitial pneumonitis or pulmonary fibrosis
Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial studies how well Panitumumab-IRDye800 works in making cancer cells glow during surgery for patients with malignant glioma. The glowing effect helps surgeons see and remove the tumor more accurately. Panitumumab-IRDye800 has been evaluated for its potential as a targeting agent for fluorescence detection of glioblastoma multiforme and high-grade gliomas.
Who is the study for?
This trial is for individuals who are scheduled for brain tumor surgery and have a malignant glioma. They must be deemed eligible for resection by their surgeon, may have had previous treatments like chemotherapy or radiation, and need to have an adequate platelet count. People with recent heart issues, history of bad reactions to monoclonal antibodies, pregnant or breastfeeding women, certain abnormal lab values, lung conditions like interstitial pneumonitis or pulmonary fibrosis can't participate.
What is being tested?
The study is testing the safety and optimal dose of Panitumumab-IRDye800 during surgery in patients with malignant glioma. This substance binds to tumor cells making them glow under a special camera so surgeons can see the cancer more clearly compared to normal brain tissue.
What are the potential side effects?
Potential side effects include reactions related to infusion of the drug such as allergic responses. Since it's used during surgery, risks associated with surgical procedures also apply.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery to remove a suspected brain tumor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had interstitial pneumonitis or pulmonary fibrosis.
Select...
I am taking medication for heart rhythm problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Optimal Timing of Surgical Procedure
Panitumumab
Tumor to background ratio (TBR)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3 -100mg panitumumab-IRDye800Experimental Treatment4 Interventions
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
Group II: Cohort 2 -100mg panitumumab-IRDye800Experimental Treatment4 Interventions
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.
Group III: Cohort 1 -50mg panitumumab-IRDye800Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
FDA approved
Panitumumab
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain cancer include monoclonal antibodies, chemotherapy, radiation therapy, and targeted therapies. Monoclonal antibodies like Panitumumab-IRDye800 target specific proteins on cancer cells, such as EGFR, and can be conjugated with fluorescent dyes to enhance tumor visibility during surgery, aiding in more precise removal of cancerous tissue.
Chemotherapy uses drugs to kill rapidly dividing cells, while radiation therapy uses high-energy rays to destroy cancer cells. Targeted therapies focus on specific molecular pathways involved in cancer growth and survival.
These treatments are crucial for brain cancer patients as they offer more precise and effective ways to target and eliminate cancer cells, potentially improving outcomes and reducing damage to surrounding healthy tissue.
Find a Location
Who is running the clinical trial?
Eben RosenthalLead Sponsor
8 Previous Clinical Trials
150 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,169,604 Total Patients Enrolled
Gordon LiPrincipal InvestigatorStanford University
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor cannot be surgically removed due to its location or other factors.I've had chemotherapy, radiation, or a biopsy and am considered a candidate for surgery.My surgeon has approved me for surgery.I have had interstitial pneumonitis or pulmonary fibrosis.I am having surgery to remove a suspected brain tumor.I am taking medication for heart rhythm problems.I haven't had a heart attack, stroke, severe heart failure, liver disease, or unstable chest pain in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 -50mg panitumumab-IRDye800
- Group 2: Cohort 2 -100mg panitumumab-IRDye800
- Group 3: Cohort 3 -100mg panitumumab-IRDye800
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.