Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

Status unconfirmed · Phase 1

Conditions studied: Brain Tumor

In brief

This research study is studying a drug called Demeclocycline that may help brain surgeons see tumors with a microscope during surgery.

Key facts

Study ID

NCT02740933

Run by

Massachusetts General Hospital

People needed

40

Starts

2016-04-01

Expected to finish

2021-01-01

Last updated by the study team

2016-04-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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