Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Trial ID or NCT#

NCT03510208

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 1) One of the following:
  2. 1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma
  3. 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.
  4. 3) Participant age ≥ 18 years.
  5. 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. 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 therapies4. 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:
  2. 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 normal7. 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.
View All Criteria
Show Less

Investigator(s)

Gordon Li, MD
Gordon Li, MD
Neurosurgeon
Professor of Neurosurgery and, by courtesy, of Neurology and Neurological Sciences and of Otolaryngology - Head & Neck Surgery (OHNS)
Steven D. Chang, MD
Steven D. Chang, MD
Neurosurgeon, Aneurysm neurosurgeon, Cerebrovascular neurosurgeon, Pituitary tumors neurosurgeon, Stereotactic neurosurgeon
Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology and Neurological Sciences
Melanie Hayden Gephart
Melanie Hayden Gephart
Neurosurgeon
Professor of Neurosurgery and, by courtesy, of Neurology and Neurological Sciences
Reena Thomas, MD PhD
Reena Thomas, MD PhD
Neuro-oncologist
Clinical Professor, Adult Neurology Clinical Professor (By courtesy), Neurosurgery
Chirag Patel, MD, PhD

Contact us to find out if this trial is right for you.

Contact

Sandra Torres
650-723-5281

SEND MESSAGE

View on ClinicalTrials.gov