Using a special dye to improve surgery for brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Lindsay Moore, MD — Stanford University
• Study coordinator: Sandra Torres
• Email: sandraet@stanford.edu
• Phone: (650) 723-5281

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target CAR-NK cell therapy for recurrent glioblastoma and high-grade glioma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.