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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577966
• Other study ID #: UAB 1108
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: May 12, 2016
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Drug:
• Sulfasalazine
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 2 years	No
Secondary	Safety will be analyzed for all patients treated in study		up to 2 years	Yes