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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trialstudies a dye that can show surgeons tumor cells in the brain during surgery, helping them to better remove cancer and identify small tumors.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Optimal Timing of Surgical Procedure
Panitumumab
Tumor to background ratio (TBR)
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
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
2,701 Previous Clinical Trials
7,506,854 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other scientific trials have been conducted using the drug combination of Cohort 3 -100mg panitumumab-IRDye800?
"Currently, 33 active trials are examining the efficacy of Cohort 3 -100mg panitumumab-IRDye800; with three in Phase 3. Though a majority of these studies take place in Nagoya-shi, Aichi, there are over 500 other sites around the world testing out this regimen."
Answered by AI
What is the current capacity of participants for this clinical research?
"Verified. Clinicaltrials.gov confirms that the recruitment process for this medical trial, which was first unveiled on May 16th 2018, is presently underway. The study is hoping to find 11 people from a single centre to join their research team."
Answered by AI
Does this research endeavor still have capacity for new participants?
"As per the listing on clinicaltrials.gov, this medical trial is still in need of participants. It was first posted on May 16th 2018 and edited most recently on October 17th 2022."
Answered by AI
Is this endeavor a pioneering experiment in its field?
"Currently, 33 clinical trials pertaining to Cohort 3 -100mg panitumumab-IRDye800 are taking place in 141 cities and 15 countries. The inaugural investigation of this drug began in 2011 with an Amgen funded Phase 2 trial that placed 75 patients under observation; since then 102 further studies have been conducted."
Answered by AI
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