Panitumumab-IRDye800 for Brain Tumor

Overseen By Nancy Sweeters

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Stanford University

Must not be taking: Antiarrhythmics

Disqualifiers: MI, CHF, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1-5 days

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment called panitumumab-IRDye800, a fluorescent imaging agent, in children and young adults undergoing brain surgery for suspected tumors. The goal is to determine the treatment's safety during tumor removal. Different groups in the trial will receive varying doses to identify the safest amount. Eligible participants have a suspected brain tumor and are already scheduled for surgery. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain heart rhythm medications like quinidine, procainamide, dofetilide, amiodarone, or sotalol.

Is there any evidence suggesting that panitumumab-IRDye800 is likely to be safe for humans?

Research has shown that Panitumumab-IRDye800 is safe. This treatment helps doctors see brain tumors more clearly during surgery. Studies have demonstrated that it provides clear images of tumors without causing serious side effects. In one study, the treatment was safe at different doses and helped highlight small tumor fragments.

Since this trial is in the early stages, researchers are closely monitoring safety. Early trials mainly focus on determining a treatment's safety for people. So far, reports indicate that Panitumumab-IRDye800 is well-tolerated, meaning it doesn’t cause many problems for participants.

For those considering joining a trial, this information may provide confidence in the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Panitumumab-IRDye800 for brain tumors because it represents a novel approach to targeting cancer cells. Unlike traditional treatments like surgery, radiation, and chemotherapy, which can affect both healthy and cancerous cells, Panitumumab-IRDye800 combines an antibody specifically targeting tumor cells with a fluorescent dye. This unique mechanism allows for precise visualization and targeting of tumor cells during surgery, potentially improving surgical outcomes and reducing damage to healthy brain tissue. Additionally, the use of varying doses in different cohorts could help optimize its effectiveness and safety.

What evidence suggests that Panitumumab-IRDye800 might be an effective treatment for brain tumors?

Research has shown that Panitumumab-IRDye800 can help surgeons see brain tumors more clearly during surgery, potentially improving tumor removal. This trial will evaluate different dosages of Panitumumab-IRDye800, with participants assigned to various dosage cohorts. The treatment uses special imaging to highlight tumor areas, making the tumor edges easier to see. Studies have demonstrated a 100% success rate in identifying tumor areas, consistently locating the tumor. Additionally, it distinguishes between tumor and non-tumor tissue more effectively than some other methods. These features may lead to better surgical outcomes and improved survival for patients with brain tumors. ^{2 4 5 6 7}

Who Is on the Research Team?

Laura Prolo, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 6 months and 25 years old.

You are expected to live for at least 12 more weeks.

I am having surgery to remove a suspected brain tumor as part of my standard treatment.

Exclusion Criteria

You have taken an experimental drug within the past month before starting treatment with Panitumumab IRDye800.

I have had interstitial pneumonitis or pulmonary fibrosis.

Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an infusion of Panitumumab-IRDye800 followed by surgical resection of the tumor

1-5 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

3 visits (in-person) on Day 1-5, Day 15, and Day 30

What Are the Treatments Tested in This Trial?

Interventions

• Panitumumab-IRDye800

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 4-1.0 Panitumumab-IRDye800 Experimental Treatment 4 Interventions

Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)

Group II: Cohort 3-0.50 Panitumumab-IRDye800 Experimental Treatment 4 Interventions

Dose: 0.50 Panitumumab-IRDye800 (mg/kg)

Group III: Cohort 2-0.25 Panitumumab-IRDye800 Experimental Treatment 4 Interventions

Dose: 0.25 Panitumumab-IRDye800 (mg/kg)

Group IV: Cohort 1-0.006 Panitumumab-IRDye800 Experimental Treatment 4 Interventions

Dose: 0.006 Panitumumab-IRDye800 (mg/kg)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A prototype glioma cancer vaccine using a mix of antigens from both patient and donor tumor tissues showed promise in stopping tumor growth in a rat model of malignant glioma.

The vaccine was particularly effective when combined with immunostimulants like Bacille Calmette Guerin (BCG) and interleukin-2, or the TLR 7/8 activator resiquimod, indicating that these combinations enhance the immune response against the tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Therapeutic Efficacy of Glioma Vaccines Based on Allo- and Syngeneic Antigens and Distinct Immunological Costimulation Activators. Stathopoulos, A., Pretto, C., Devillers, L., et al.[2021]

In a phase 3 trial involving 745 patients with newly diagnosed glioblastoma, the addition of the vaccine rindopepimut to standard chemotherapy did not significantly improve overall survival compared to the control group, with median survival times of 20.1 months versus 20.0 months, respectively.

The study was terminated for futility after an interim analysis, indicating that rindopepimut alone may not be effective in enhancing survival outcomes, suggesting that combination therapies may be necessary for immunotherapy to be effective in treating glioblastoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Weller, M., Butowski, N., Tran, DD., et al.[2023]

Rindopepimut, an immunotherapy targeting the EGFRvIII mutation, is the first of its kind to enter Phase III clinical trials for treating recurrent glioblastoma, a highly aggressive brain tumor.

The ReACT Phase II trial evaluated the combination of rindopepimut and bevacizumab in patients with EGFRvIII-positive recurrent glioblastoma, highlighting the potential of this approach to activate the immune response against tumor cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReACT Phase II trial: a critical evaluation of the use of rindopepimut plus bevacizumab to treat EGFRvIII-positive recurrent glioblastoma. Gatson, NT., Weathers, SP., de Groot, JF.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7483817/

Comparison of Panitumumab-IRDye800CW and 5 ... Panitumumab-IRDye800CW and 5-ALA showed 100% sensitivity for margin as well as core tumor area. However, panitumumab-IRDye800CW showed higher specificity than 5 ...

2. withpower.com withpower.com/trial/phase-2-neoplasms-4-2018-709c4

Panitumumab-IRDye800 for Brain Cancer Research shows that Panitumumab-IRDye800 can help surgeons see brain tumors more clearly during surgery, which may lead to better removal of the tumor. In ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8210618/

EGFR-targeted intraoperative fluorescence imaging detects ... EGFR-targeted intraoperative fluorescence imaging detects high-grade glioma with panitumumab-IRDye800 in a phase 1 clinical trial.

4. aacrjournals.org aacrjournals.org/mct/article-pdf/doi/10.1158/1535-7163.MCT-19-0819/1916824/1535-7163_mct-19-0819v2.pdf

Comparison of Panitumumab-IRDye800CW and 5 ... Improved margin definition and surgical resection using panitumumab-IRDye800 has the potential to improve surgical outcomes and survival in patients with GBM ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03510208

Study Details | NCT03510208 | Panitumumab-IRDye800 in ... The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34158840/

EGFR-targeted intraoperative fluorescence imaging detects ... Conclusions: Panitumumab-IRDye800 provided excellent tumor contrast and was safe at both doses. Smaller fragments of tumor could be detected ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4241857/

Synthesis and biological evaluation of panitumumab ... We developed clinical-quality panitumumab-IRDye800 and evaluated its specificity and sensitivity to visualize tumors by fluorescence imaging.