Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Description

The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.

Conditions

Malignant Brain Neoplasm, Malignant Glioma

Talk to us

Study Overview

On this page

Study Details

Study overview

The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.

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

Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Condition
Malignant Brain Neoplasm
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University School of Medicine, Palo Alto, California, United States, 94304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible; these may include subjects' status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are assessed to be candidates for resection
  • * Subjects must be eligible for resection as determined by the operating surgeon
  • * Platelet count ≥ 75,000/mm\^3
  • * Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
  • * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  • * History of infusion reactions to monoclonal antibody therapies
  • * Pregnant or breastfeeding
  • * Evidence of corrected QT (QTc) prolongation on pre-treatment electrocardiography (ECG) (greater than 440ms in males or greater than 460ms in females)
  • * Thyroid-stimulating hormone (TSH) ≥ 13 micro international units/mL
  • * Magnesium, potassium and calcium \< the lower limit of normal per institution normal lab values
  • * Other lab values that in the opinion of the primary surgeon would prevent surgical resection
  • * Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  • * Subjects not deemed 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eben Rosenthal,

Gordon Li, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2024-12-31