Brain Tumor
Conditions
Keywords
Brain Tumor Surgery
Brief summary
This research study is studying a drug called Demeclocycline that may help brain surgeons see tumors with a microscope during surgery.
Detailed 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.
Interventions
DRUGDemeclocycline
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detectable fluorescence in brain tumors by confocal microscopy after oral dosing of demeclocycline (Y/N). | 2 years | Detectable fluorescence via confocal microscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity And Specificity Of Demeclocycline-Enhanced Multimodal Confocal Microscopy of Excised Glioma Specimens | 2 years | We aim to measure the sensitivity and specificity with which tumors can be diagnosed accurately after satisfactory detection of fluorescence |
Countries
United States
Contacts
Primary ContactWilliam T Curry, MD
Outcome results
None listed