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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arginine | Experimental | 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. |
|
| Silica and cellulose placebo powder | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arginine in powder form | Drug |
| ||
| Silica and cellulose placebo powder |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GBM patients immune function through arginine supplementation | 25% increase in the functional response of peripheral T cells | study day 0 and 8 |
| Change in control group immune function through arginine supplementation | Observe the change in T cell functional response | Study days 0 and 8 |
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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:
Written informed consent is obtained prior to initiation of study procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Waziri, MD | Inova Health Care Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Outpatient Surgery Clinic and Inova Fairfax Hospital | Fairfax | Virginia | 22031 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| D012822 | Silicon Dioxide |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Drug |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D000601 | Amino Acids, Essential |
| D008903 | Minerals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017655 | Silicon Compounds |