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Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma

Primary Purpose

Brain Tumor

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sulfasalazine

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Patients with brain tumors associated with seizures

Eligibility Criteria

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

Inclusion Criteria:

Patients must be > 18 years of age or older.
Patients must have histologically proven low grade astrocytoma,anaplastic astrocytoma, anaplastic mixed glioma, anaplastic oligodendroglioma,glioblastoma multiforme, astrocytoma WHO II,oligodendroglioma WHO II or mixed glioma WHO II. Patients do not haveto demonstrate progressive disease to participate in this study.
Patients must have completed initial glioma therapy involving radiation and be 3 months from the completion of radiation therapy. If initial glioma therapy did not include radiation (example: anaplastic oligodendroglioma), then 2 cycles of chemotherapy must be completed prior to study entry.
Patients must be maintained on a stable corticosteroid regimen for > 5 days prior to entry.
Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
Patients must have adequate hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine > 1.5 mg/dl.
Women of childbearing potential must have a negative pregnancy test.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effect of the investigational drugs on the developing human fetus is not known, but these drugs are likely to be harmful to the developing fetus or nursing infant. Women of child-bearing potential must agree to use adequate contraception (either surgical sterilization; approved hormonal contraceptives such as birth control pills: Depo-Provera, or Lupron Depot; barrier methods such as condom or diaphragm along with spermicide; or an IUD). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study PI immediately.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Pregnant or breast feeding.
Exclude sexually active males and females unwilling to practice contraception during the study.
Serious concurrent infections.
Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Patients with other serious uncontrolled co-morbid diseases that the investigator feels may comprise the study findings.
Allergic or sensitivity to sulfa containing medications.

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sulfasalazine

Arm Description

Outcomes

Primary Outcome Measures

Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine

To determine the ability of sulfasalazine to alter glioma glutamate levels. These levels will be measured by Magnetic Resonance Spectroscopy (MRS). The percent change is noted per subject. The measure is a % decrease of glioma glutamate levels

Secondary Outcome Measures

Full Information

NCT ID

NCT01577966

First Posted

April 11, 2012

Last Updated

October 16, 2016

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT01577966

Brief Title

Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma

Official Title

A Pilot Study to Determine the Effect of Sulfasalazine on Glutamate Levels Detected by Magnetic Resonance Spectroscopy(MRS) in Patients With Glioma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this part of the study is to determine the Central Nervous System bioavailability of sulfasalazine.

Detailed Description

This is a pilot, open-label, non-randomized, study to determine the effect that orally administered sulfasalazine has on glutamate levels as measured by MRS and on epileptiform spiking as measured by simultaneous MEG/EEG. The intent of the dose escalation is to determine an Optimal Biological Dose (OBD) based on changes in tumor glutamate levels. The OBD is defined as the dose that has the maximal reduction in tumor glutamate levels after normalization to uninvolved brain.

6. Conditions and Keywords

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

Brain Tumor

Keywords

Patients with brain tumors associated with seizures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sulfasalazine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sulfasalazine

Intervention Description

Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA.

Primary Outcome Measure Information:

Title

Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine

Description

Time Frame

up to 2 years post baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be > 18 years of age or older. Patients must have histologically proven low grade astrocytoma,anaplastic astrocytoma, anaplastic mixed glioma, anaplastic oligodendroglioma,glioblastoma multiforme, astrocytoma WHO II,oligodendroglioma WHO II or mixed glioma WHO II. Patients do not haveto demonstrate progressive disease to participate in this study. Patients must have completed initial glioma therapy involving radiation and be 3 months from the completion of radiation therapy. If initial glioma therapy did not include radiation (example: anaplastic oligodendroglioma), then 2 cycles of chemotherapy must be completed prior to study entry. Patients must be maintained on a stable corticosteroid regimen for > 5 days prior to entry. Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others). Patients must have adequate hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine > 1.5 mg/dl. Women of childbearing potential must have a negative pregnancy test. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effect of the investigational drugs on the developing human fetus is not known, but these drugs are likely to be harmful to the developing fetus or nursing infant. Women of child-bearing potential must agree to use adequate contraception (either surgical sterilization; approved hormonal contraceptives such as birth control pills: Depo-Provera, or Lupron Depot; barrier methods such as condom or diaphragm along with spermicide; or an IUD). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study PI immediately. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Pregnant or breast feeding. Exclude sexually active males and females unwilling to practice contraception during the study. Serious concurrent infections. Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months. Patients with other serious uncontrolled co-morbid diseases that the investigator feels may comprise the study findings. Allergic or sensitivity to sulfa containing medications.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis B Nabors, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

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Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma

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