What side effects are associated with this type of intervention?

Common treatments for brain cancer, particularly those involving monoclonal antibodies targeting EGFR like Panitumumab-IRDye800, often result in side effects such as skin rash, infusion-related reactions, and gastrointestinal issues like diarrhea. Other systemic chemotherapy agents used in brain cancer treatment can cause fatigue, nausea, vomiting, and hematologic toxicities such as neutropenia and thrombocytopenia. Additionally, targeted therapies may lead to specific toxicities like hypomagnesemia and venous thromboembolism.

What prior FDA approvals exist?

The FDA has approved several treatments for brain cancer that involve monoclonal antibodies and targeted therapies. One notable example is bevacizumab, a monoclonal antibody targeting VEGF, which is used for recurrent glioblastoma. Additionally, 5-aminolevulinic acid (5-ALA) is approved for use in fluorescence-guided surgery to enhance tumor visibility, similar to the investigational Panitumumab-IRDye800. These treatments aim to improve surgical outcomes and target specific pathways involved in tumor growth.

What other types of research exist?

Promising novel alternatives to Panitumumab-IRDye800 for brain cancer patients include: 1) Tumor Treating Fields (TTFields) - a non-invasive treatment that uses electric fields to disrupt cancer cell division. 2) CAR-T cell therapy - a type of immunotherapy where a patient's T cells are modified to target cancer cells. 3) Oncolytic virus therapy - using genetically modified viruses to selectively infect and kill cancer cells. 4) Advanced imaging agents like 5-ALA (5-aminolevulinic acid) which makes tumor cells fluoresce under specific light during surgery. These alternatives are in various stages of clinical trials and have shown potential in improving treatment outcomes for brain cancer patients.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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

0 / 3Eligibility criteria met

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.