Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma
Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma
The main purpose of this part of the study is to determine the Central Nervous System
 bioavailability of sulfasalazine.
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
 entry.

 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 document.

 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.