Panitumumab-IRDye800 for Brain Tumor

Overseen By Vyviann Ngo

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Stanford University

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

Trial Summary

What is the purpose of this trial?

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

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.

What makes Panitumumab-IRDye800 unique for treating brain tumors?

Panitumumab-IRDye800 is unique because it combines a targeted therapy with a fluorescent dye, allowing surgeons to better visualize and remove brain tumors during surgery. This approach is different from standard treatments, which typically do not include a component to enhance surgical precision. ^{1 2 3 4 5}

Research Team

Gerald Grant, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2018]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Exploring the Therapeutic Efficacy of Glioma Vaccines Based on Allo- and Syngeneic Antigens and Distinct Immunological Costimulation Activators. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Rindopepimut: a promising immunotherapeutic for the treatment of glioblastoma multiforme. [2021]