Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

Last updated: April 12, 2016
Sponsor: Massachusetts General Hospital
Overall Status: Active - Not Recruiting

Phase

1

Condition

Gliomas

Brain Tumor

Memory Loss

Treatment

N/A

Clinical Study ID

NCT02740933
15-280
  • Ages > 21
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must present with a gadolinium-enhancing brain lesion (or lesions) thatare thought by the neuroradiologist and the neurosurgeon to be consistent withhigh-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 FDApregnancy category D. Maternal ingestion of Tetracyclines during pregnancy may causetooth discoloration, enamel defects, and other congenital anomalies. Tetracyclines areexcreted in human breast milk; however, the extent of absorption of Tetracyclines bythe 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 removingmore tissue than what would be taken for a biopsy.

Exclusion

Exclusion Criteria:

  • History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to Demeclocycline.

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements.

  • Pregnant and/or nursing women are excluded from this study because Demeclocycline is aknown Teratogenic agent, pregnancy category D. It is known to be excreted in breastmilk.

  • 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).

Study Design

Total Participants: 40
Study Start date:
April 01, 2016
Estimated Completion Date:
January 31, 2021

Study Description

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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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