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Efficacy Study of Oral Arginine to Improve Immune Function in Glioblastoma Multiforme

Study Purpose

The purpose of this study is to learn more about the ability of a substance called arginine to improve the functioning of the immune system in people with a certain type of brain tumor. This could lead to improvements in a type of treatment for brain tumors called immunotherapy. The immune system includes organs, cells, and substances in the body that fight infection and disease. Immunotherapy is a type of treatment that uses the immune system as a tool to seek out and destroy abnormal cells. Immunotherapy requires that the immune system be working properly. Arginine is a normal component of protein (an amino acid) that we all consume in foods such as red meat, poultry, fish, and dairy products and that our bodies can make. Arginine helps the immune system function normally. Recent research has shown that certain types of brain tumors decrease the amount of arginine in the body leading to impaired immune system function. This may interfere with the ability of immunotherapy to fight abnormal cells. We would like to see if giving people with brain tumors arginine in powder form will make their immune systems work better.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age 18 and above. 2. Imaging consistent with GBM without clinical indication for primary CNS lymphoma or abscess, as determined by the treating physician. 3. Patient must be planned to proceed to definitive surgery intended for tumor resection, rather than needle biopsy, within a reasonable time frame from initial evaluation (7-14 days). 4. Patient must be neurologically stable, allowing for reasonable time frame between initial evaluation and subsequent surgical procedure (7-14 days). 5. Patient must have initial KPS greater than 80. 6. At the time of initial evaluation the patient must be on a stable dose of steroid medication if indicated. 7. Patient must have laboratory values, as determined by institutional controls, within the following parameters:
  • - White blood cell count above lowest level for normal range.
  • - Renal function within normal limits (creatinine, BUN) - Liver function within normal limits (AST/ALT, total bilirubin, alkaline phosphatase) 8.
Written informed consent is obtained prior to initiation of study procedures.

Exclusion Criteria:

1. Known autoimmune condition, underlying immune disease, or use of immunomodulatory prescription drugs (aside from steroids) for any medical condition. 2. Prescribed vasodilator medications: Phosphodiesterase Inhibitors: Sildenafil (Viagra), Nitrates, Alpha blockers: Terazosin (Hytrin), doxazosin (Cardura), alfuzosin (Uroxatral), tamsulosin (Flomax), and prazosin (Minipress). 3. Glaucoma. 4. Known Herpes simplex virus (i.e. cold sores) 5. History of myocardial infarction or coronary artery disease. 6. Known allergy or intolerance to arginine. 7. Uncontrolled or poorly controlled seizures. 8. KPS less than 80. 9. Known renal or hepatic insufficiency or failure. 10. Known deficiency or dysfunction of intestinal absorption or motility. 11. History of other malignancy regardless of current status or treatment. 12. Underlying psychiatric condition or altered mental status that would violate stringent acquisition of informed consent or potentially preclude, in the opinion of the investigator, compliance with study requirements. 13. Pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02017249
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Inova Health Care Services
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Allen Waziri, MD
Principal Investigator Affiliation Inova Health Care Systems
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Arginine

24.15g of arginine supplement in powder form will be administered orally 3 times per day for 7 days before surgery and 7 days after surgery.

Placebo Comparator: Silica and cellulose placebo powder

3.5 teaspoons of placebo powder will be mixed with a sweet beverage and given orally 3 times per day for 7 days prior to surgery and 7 days after surgery.

Interventions

Drug: - arginine in powder form

Drug: - Silica and cellulose placebo powder

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fairfax, Virginia

Status

Address

Inova Outpatient Surgery Clinic and Inova Fairfax Hospital

Fairfax, Virginia, 22031