Trial Outcomes & Findings for Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma (NCT NCT01577966)

Last Updated: 2016-12-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

up to 2 years post baseline

Results posted on

2016-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	Sulfasalazine Sulfasalazine
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sulfasalazine n=9 Participants 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.
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 years post baseline

Outcome measures

Outcome measures
Measure	Sulfasalazine n=9 Participants 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.
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine GBM Pt 2	17 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine GBM Pt 1	23 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine GBM Pt 4	28 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine Astro Pt 3	5 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine Astro Pt 9	55 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine Astro Pt 5	58 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine Oligo Pt 8	12 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine Oligo Pt 6	18 percentage of change
Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine Oligo Pt 7	42 percentage of change

Adverse Events

Sulfasalazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Burt Nabors, MD

UAB

Phone: 205-934-2424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place