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New treatment option for Malignant Brain Neoplasm
Official title Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
ClinicalTrials.gov ID: NCT03510208
What this study is testing
What is Panitumumab?
Panitumumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant brain neoplasm.
Also referred to as ABX-EGF, ABX-EGF Monoclonal Antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1) One of the following:
- Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
- Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma 2.) Planned surgical removal of the tumor as part of standard...
You likely can't join if
- 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 as determined by...
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding.
- Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
- Any of the following lab values:
See the full eligibility criteria
- 1) One of the following:
- Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
- 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...
- 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 as determined by PI; or unstable angina within 6 months prior to enrollment.
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding.
- Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
- Any of the following lab values:
- Platelet count \< 75,000/mm3
- TSH ≥ 13 micro International Units/mL.
- Magnesium, potassium, or calcium \< each respective upper limit of normal
- Serum creatinine \> 1.5 times upper limit of normal
- Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.