This pilot clinical trial studies the best way to give and best dose of demeclocycline hydrochloride in detecting tumor cells during brain surgery in patients with malignant glioma. Demeclocycline hydrochloride is a commonly used antibiotic that can bind to brain tumor tissue and cause it to glow brightly when viewed with a special microscope. Giving demeclocycline hydrochloride to patients before surgery may improve how well surgeons can see brain tumors with a microscope during surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT02740933.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the duration of exposure to orally delivered demeclocycline hydrochloride (demeclocycline) at which fluorescence can be visualized in malignant glioma tissue, using confocal optical imaging of excised specimens.
SECONDARY OBJECTIVES:
I. To determine that demeclocycline – enhanced multimodal confocal optical imaging permits accurate histological diagnosis of glial tumors in patients undergoing craniotomy for resection of gadolinium-enhancing malignant gliomas.
OUTLINE: This is a dose-escalation study.
Patients receive demeclocycline hydrochloride orally (PO) twice a day (BID) for 2-5 days. Patients then undergo craniotomy for resection of malignant gliomas 24-48 hours after the last dose of demeclocycline hydrochloride. During surgery, brain tissue is surgically removed and collected for examination with confocal microscopy.
After completion of study treatment, patients are followed up for 3 months.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorWilliam Thomas Curry
