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Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

Primary Purpose

Brain Tumor

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Demeclocycline

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Brain Tumor Surgery

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Demeclocycline

Arm Description

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.

Outcomes

Primary Outcome Measures

Detectable fluorescence in brain tumors by confocal microscopy after oral dosing of demeclocycline (Y/N).

Detectable fluorescence via confocal microscopy

Secondary Outcome Measures

Sensitivity And Specificity Of Demeclocycline-Enhanced Multimodal Confocal Microscopy of Excised Glioma Specimens

We aim to measure the sensitivity and specificity with which tumors can be diagnosed accurately after satisfactory detection of fluorescence

Full Information

NCT ID

NCT02740933

First Posted

March 15, 2016

Last Updated

April 12, 2016

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02740933

Brief Title

Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

Official Title

Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor

Keywords

Brain Tumor Surgery

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Demeclocycline

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Demeclocycline

Other Intervention Name(s)

Declomycin

Primary Outcome Measure Information:

Title

Detectable fluorescence in brain tumors by confocal microscopy after oral dosing of demeclocycline (Y/N).

Description

Detectable fluorescence via confocal microscopy

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Sensitivity And Specificity Of Demeclocycline-Enhanced Multimodal Confocal Microscopy of Excised Glioma Specimens

Description

We aim to measure the sensitivity and specificity with which tumors can be diagnosed accurately after satisfactory detection of fluorescence

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

William T Curry, MD

Phone

617-726-3779

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William T Curry, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William T Curry, MD

Phone

617-726-3779

First Name & Middle Initial & Last Name & Degree

William T Curry, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We plan to present on and publish the data acquired from this study.

Citations:

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Citation

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Citation

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Demeclocycline Fluorescence for Intraoperative Delineation Brain Tumors

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