Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

This research study is a Feasibility Study, which is the first time investigators are
examining this study intervention.The FDA (the U.S. Food and Drug Administration) has not
approved Demeclocycline for your specific disease but it has been approved for other uses.

In this research study, the investigators would like to determine the lowest dose of
Demeclocycline that will allow surgeons to detect tumor cells during surgery. These cells
will be marked through a process called fluorescence, which will cause tumor cells to glow
brightly on an image in comparison to its surroundings.

Inclusion Criteria:

- Participants must present with a gadolinium-enhancing brain lesion (or lesions) that
are thought by the neuroradiologist and the neurosurgeon to be consistent with
high-grade glioma. These may be newly diagnosed lesions or recurrent tumors.

- The patient must not be pregnant or nursing. Tetracycline (Demeclocycline,
Doxycycline, Minocycline, Tetracycline, and Tigecycline) are classified as FDA
pregnancy category D. Maternal ingestion of Tetracyclines during pregnancy may cause
tooth discoloration, enamel defects, and other congenital anomalies. Tetracyclines
are excreted in human breast milk; however, the extent of absorption of Tetracyclines
by the breastfed infant is not known.

- Participants must have normal organ and marrow function as defined below:

- leukocytes ≥ 3,000/mcL

- absolute neutrophil count ≥ 1,500/mcL

- platelets ≥ 100,000/mcL

- total bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) ≤ 4 × institutional upper limit of normal

- creatinine < 2mg/dL

- Ability to understand and the willingness to sign a written informed consent
document.

- Participants must be undergoing a surgical procedure with the intention of removing
more tissue than what would be taken for a biopsy.

Exclusion Criteria:

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Demeclocycline.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant and/or nursing women are excluded from this study because Demeclocycline is
a known Teratogenic agent, pregnancy category D. It is known to be excreted in breast
milk.

- Patients taking etinoid medications by mouth (such as Acitretin, Isotretinoin),
Strontium Ranelate may not take Demeclocycline because of toxic interactions

- Patients taking any tetracycline class of drug (i.e. Minocycline, etc).