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

19 Years
Open (Enrolling)
Brain Tumor

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Trial Information

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

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.

Inclusion Criteria:

1. Patients must be > 18 years of age or older.

2. 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.

3. 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.

4. Patients must be maintained on a stable corticosteroid regimen for > 5 days prior to

5. 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).

6. 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.

7. Women of childbearing potential must have a negative pregnancy test.

8. 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.

9. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

1. Pregnant or breast feeding.

2. Exclude sexually active males and females unwilling to practice contraception during
the study.

3. Serious concurrent infections.

4. 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.

5. Patients with other serious uncontrolled co-morbid diseases that the investigator
feels may comprise the study findings.

6. Allergic or sensitivity to sulfa containing medications.

Type of Study:


Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Central Nervous System Bioavailability of Sulfasalazine

Outcome Description:

To determine the ability of sulfasalazine to alter glioma glutamate levels. These levels will be measured by Magnetic Resonance Spectroscopy (MRS).

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Louis B Nabors, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Food and Drug Administration

Study ID:

UAB 1108



Start Date:

January 2012

Completion Date:

May 2014

Related Keywords:

  • Brain Tumor
  • Patients with brain tumors associated with seizures
  • Brain Neoplasms



University of Alabama at BirminghamBirmingham, Alabama  35294-3300