Using a special dye to improve surgery for brain tumors

Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures

This study is testing a special dye that helps doctors see brain tumors better during surgery to improve outcomes for people with malignant glioma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Drugs / interventions: Panitumumab, radiation
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT03510208 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of panitumumab-IRDye800, a dye that binds to tumor cells, making them more visible during surgery for malignant glioma. The study aims to determine the best dosage and timing for using this imaging agent to enhance the distinction between tumor and normal brain tissue. Participants will undergo surgery with the hope that this approach will lead to better surgical outcomes by identifying small tumors that current imaging methods may miss.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with suspected or confirmed malignant glioma who are scheduled for surgical tumor removal.

Not a fit: Patients who have received an investigational drug within 30 days prior to the study or have certain cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the accuracy of tumor removal during surgery, potentially leading to better patient outcomes.

How similar studies have performed: Other studies using similar imaging techniques have shown promise, suggesting that this approach may be effective, though this specific application is novel.

Eligibility criteria

Inclusion Criteria:

1\) One of the following:

1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma

   2.) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and/or participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.

   3\) Participant age ≥ 18 years.

   4\) Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

1. Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.
2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment.
3. History of infusion reactions to monoclonal antibody therapies
4. Pregnant or breastfeeding.
5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
6. Any of the following lab values:

   1. Platelet count \< 75,000/mm3
   2. TSH ≥ 13 micro International Units/mL.
   3. Magnesium, potassium, or calcium \< each respective upper limit of normal
   4. Serum creatinine \> 1.5 times upper limit of normal
7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. Participants not deemed by PI to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here.

Where this trial is running

Palo Alto, California

• Stanford University School of Medicine — Palo Alto, California, United States (Recruiting)

Study contacts

• Principal investigator: Gordon Li, MD — Stanford University
• Study coordinator: Sandra Torres

Conditions Malignant Brain Neoplasm; Malignant Glioma