Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors
NCT ID: NCT02740933
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2016-04-30
2021-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Demeclocycline
All subjects will take Demeclocycline 300 mg po bid. Patients will be advised to take demeclocycline on an empty stomach, at least 1-2 hours before meals, and they will be warned that it can reduce the efficacy of oral contraceptives.
The investigators will begin by treating subjects with 2 days of demeclocycline. The investigators will increase the numbers of days that subjects are exposed to demeclocycline in increments of 1 day until at least 80% of patients at a given dose have detectably fluorescent tumors, or participants reach 5 days of drug, whichever comes first.
Demeclocycline
Interventions
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Demeclocycline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
21 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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William T. Curry, MD
William T. Curry, MD
Principal Investigators
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William T Curry, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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William T Curry, MD
Role: CONTACT
Facility Contacts
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William T Curry, MD
Role: primary
References
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Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
Pichlmeier U, Bink A, Schackert G, Stummer W; ALA Glioma Study Group. Resection and survival in glioblastoma multiforme: an RTOG recursive partitioning analysis of ALA study patients. Neuro Oncol. 2008 Dec;10(6):1025-34. doi: 10.1215/15228517-2008-052. Epub 2008 Jul 30.
Sanai N, Polley MY, McDermott MW, Parsa AT, Berger MS. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011 Jul;115(1):3-8. doi: 10.3171/2011.2.jns10998. Epub 2011 Mar 18.
McGirt MJ, Mukherjee D, Chaichana KL, Than KD, Weingart JD, Quinones-Hinojosa A. Association of surgically acquired motor and language deficits on overall survival after resection of glioblastoma multiforme. Neurosurgery. 2009 Sep;65(3):463-9; discussion 469-70. doi: 10.1227/01.NEU.0000349763.42238.E9.
Laws ER, Parney IF, Huang W, Anderson F, Morris AM, Asher A, Lillehei KO, Bernstein M, Brem H, Sloan A, Berger MS, Chang S; Glioma Outcomes Investigators. Survival following surgery and prognostic factors for recently diagnosed malignant glioma: data from the Glioma Outcomes Project. J Neurosurg. 2003 Sep;99(3):467-73. doi: 10.3171/jns.2003.99.3.0467.
Stummer W, Reulen HJ, Meinel T, Pichlmeier U, Schumacher W, Tonn JC, Rohde V, Oppel F, Turowski B, Woiciechowsky C, Franz K, Pietsch T; ALA-Glioma Study Group. Extent of resection and survival in glioblastoma multiforme: identification of and adjustment for bias. Neurosurgery. 2008 Mar;62(3):564-76; discussion 564-76. doi: 10.1227/01.neu.0000317304.31579.17.
Liu JT, Meza D, Sanai N. Trends in fluorescence image-guided surgery for gliomas. Neurosurgery. 2014 Jul;75(1):61-71. doi: 10.1227/NEU.0000000000000344.
Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. doi: 10.1016/S1470-2045(11)70196-6. Epub 2011 Aug 23.
Zehri AH, Ramey W, Georges JF, Mooney MA, Martirosyan NL, Preul MC, Nakaji P. Neurosurgical confocal endomicroscopy: A review of contrast agents, confocal systems, and future imaging modalities. Surg Neurol Int. 2014 Apr 28;5:60. doi: 10.4103/2152-7806.131638. eCollection 2014.
Sanai N, Snyder LA, Honea NJ, Coons SW, Eschbacher JM, Smith KA, Spetzler RF. Intraoperative confocal microscopy in the visualization of 5-aminolevulinic acid fluorescence in low-grade gliomas. J Neurosurg. 2011 Oct;115(4):740-8. doi: 10.3171/2011.6.JNS11252. Epub 2011 Jul 15.
Wirth D, Snuderl M, Sheth S, Kwon CS, Frosch MP, Curry W, Yaroslavsky AN. Identifying brain neoplasms using dye-enhanced multimodal confocal imaging. J Biomed Opt. 2012 Feb;17(2):026012. doi: 10.1117/1.JBO.17.2.026012.
Snuderl M, Wirth D, Sheth SA, Bourne SK, Kwon CS, Ancukiewicz M, Curry WT, Frosch MP, Yaroslavsky AN. Dye-enhanced multimodal confocal imaging as a novel approach to intraoperative diagnosis of brain tumors. Brain Pathol. 2013 Jan;23(1):73-81. doi: 10.1111/j.1750-3639.2012.00626.x. Epub 2012 Aug 28.
Wirth D, Snuderl M, Curry W, Yaroslavsky A. Comparative evaluation of methylene blue and demeclocycline for enhancing optical contrast of gliomas in optical images. J Biomed Opt. 2014 Sep;19(9):90504. doi: 10.1117/1.JBO.19.9.090504.
Other Identifiers
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15-280
Identifier Type: -
Identifier Source: org_study_id
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