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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02017249
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : September 11, 2015
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: arginine in powder form Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blinded Randomized Placebo-Controlled Trial Exploring the Efficacy of Oral ARginine Supplementation to Improve Cellular Immune Function in Patients With Glioblastoma Multiforme
Study Start Date : March 2014
Actual Primary Completion Date : September 2015

Arm Intervention/treatment
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.
Drug: arginine in powder form
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.

Primary Outcome Measures :
  1. Change in GBM patients immune function through arginine supplementation [ Time Frame: study day 0 and 8 ]
    25% increase in the functional response of peripheral T cells

  2. Change in control group immune function through arginine supplementation [ Time Frame: Study days 0 and 8 ]
    Observe the change in T cell functional response

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02017249

United States, Virginia
Inova Outpatient Surgery Clinic and Inova Fairfax Hospital
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Inova Health Care Services
Principal Investigator: Allen Waziri, MD Inova Health Care Systems

Responsible Party: Inova Health Care Services Identifier: NCT02017249     History of Changes
Other Study ID Numbers: 13-1364
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue