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

Primary Purpose

Glioblastoma Multiforme

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

arginine in powder form

Silica and cellulose placebo powder

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 and above.
Imaging consistent with GBM without clinical indication for primary CNS lymphoma or abscess, as determined by the treating physician.
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).
Patient must be neurologically stable, allowing for reasonable time frame between initial evaluation and subsequent surgical procedure (7-14 days).
Patient must have initial KPS greater than 80.
At the time of initial evaluation the patient must be on a stable dose of steroid medication if indicated.
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)
Written informed consent is obtained prior to initiation of study procedures.

Exclusion Criteria:

Known autoimmune condition, underlying immune disease, or use of immunomodulatory prescription drugs (aside from steroids) for any medical condition.
Prescribed vasodilator medications: Phosphodiesterase Inhibitors: Sildenafil (Viagra), Nitrates, Alpha blockers: Terazosin (Hytrin), doxazosin (Cardura), alfuzosin (Uroxatral), tamsulosin (Flomax), and prazosin (Minipress).
Glaucoma
Known Herpes simplex virus (i.e. cold sores)
History of myocardial infarction or coronary artery disease.
Known allergy or intolerance to arginine.
Uncontrolled or poorly controlled seizures.
KPS less than 80.
Known renal or hepatic insufficiency or failure.
Known deficiency or dysfunction of intestinal absorption or motility.
History of other malignancy regardless of current status or treatment.
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
Pregnancy

Sites / Locations

Inova Outpatient Surgery Clinic and Inova Fairfax Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arginine

Silica and cellulose placebo powder

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in GBM patients immune function through arginine supplementation

25% increase in the functional response of peripheral T cells

Change in control group immune function through arginine supplementation

Observe the change in T cell functional response

Secondary Outcome Measures

Full Information

NCT ID

NCT02017249

First Posted

November 7, 2013

Last Updated

September 12, 2019

Sponsor

Inova Health Care Services

1. Study Identification

Unique Protocol Identification Number

NCT02017249

Brief Title

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

Acronym

ArginineGBM

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 Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

October 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inova Health Care Services

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arginine

Arm Type

Experimental

Arm Description

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.

Arm Title

Silica and cellulose placebo powder

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

arginine in powder form

Intervention Type

Drug

Intervention Name(s)

Silica and cellulose placebo powder

Primary Outcome Measure Information:

Title

Change in GBM patients immune function through arginine supplementation

Description

25% increase in the functional response of peripheral T cells

Time Frame

study day 0 and 8

Title

Change in control group immune function through arginine supplementation

Description

Observe the change in T cell functional response

Time Frame

Study days 0 and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 and above. Imaging consistent with GBM without clinical indication for primary CNS lymphoma or abscess, as determined by the treating physician. 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). Patient must be neurologically stable, allowing for reasonable time frame between initial evaluation and subsequent surgical procedure (7-14 days). Patient must have initial KPS greater than 80. At the time of initial evaluation the patient must be on a stable dose of steroid medication if indicated. 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) Written informed consent is obtained prior to initiation of study procedures. Exclusion Criteria: Known autoimmune condition, underlying immune disease, or use of immunomodulatory prescription drugs (aside from steroids) for any medical condition. Prescribed vasodilator medications: Phosphodiesterase Inhibitors: Sildenafil (Viagra), Nitrates, Alpha blockers: Terazosin (Hytrin), doxazosin (Cardura), alfuzosin (Uroxatral), tamsulosin (Flomax), and prazosin (Minipress). Glaucoma Known Herpes simplex virus (i.e. cold sores) History of myocardial infarction or coronary artery disease. Known allergy or intolerance to arginine. Uncontrolled or poorly controlled seizures. KPS less than 80. Known renal or hepatic insufficiency or failure. Known deficiency or dysfunction of intestinal absorption or motility. History of other malignancy regardless of current status or treatment. 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 Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allen Waziri, MD

Organizational Affiliation

Inova Health Care Systems

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inova Outpatient Surgery Clinic and Inova Fairfax Hospital

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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