Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma
This study is currently recruiting participants.
Verified May 2013 by University of Alabama at Birmingham
Information provided by (Responsible Party):
Louis Burt Nabors, MD, University of Alabama at Birmingham
First received: April 11, 2012
Last updated: May 3, 2013
Last verified: May 2013
The main purpose of this part of the study is to determine the Central Nervous System bioavailability of sulfasalazine.
||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study to Determine the Effect of Sulfasalazine on Glutamate Levels Detected by Magnetic Resonance Spectroscopy(MRS) in Patients With Glioma
Primary Outcome Measures:
Secondary Outcome Measures:
- Safety will be analyzed for all patients treated in study [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
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.
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.
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577966
|University of Alabama at Birmingham
|Birmingham, Alabama, United States, 35294 |
|Contact: Shirley D Gibbs, BS 205-975-0447 email@example.com |
|Contact: Thiru Pillay, RN 205-934-1842 firstname.lastname@example.org |
|Principal Investigator: Louis B Nabors, MD |
University of Alabama at Birmingham
||Louis B Nabors, MD
||University of Alabama at Birmingham
No publications provided
||Louis Burt Nabors, MD, Professor, Neurology Chair Office, University of Alabama at Birmingham
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 11, 2012
||May 3, 2013
||United States: Food and Drug Administration
Keywords provided by University of Alabama at Birmingham:
Patients with brain tumors associated with seizures
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents