Glioblastoma MultiformePhase 1ArginineGBMNCT02017249
Efficacy Study of Oral Arginine to Improve Immune Function in Glioblastoma Multiforme
A Phase 1 study testing arginine in powder form in people with Glioblastoma Multiforme, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- arginine in powder form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 6 Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Outpatient Surgery Clinic and Inova Fairfax Hospital
Fairfax, Virginia, 22031
About this study
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
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- arginine in powder form, Silica and cellulose placebo powder
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arginine in powder formDrug
Silica and cellulose placebo powderDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: arginine in powder form |
| 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. Receives: Drug: Silica and cellulose placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GBM patients immune function through arginine supplementation
25% increase in the functional response of peripheral T cells
Measured: study day 0 and 8
Change in control group immune function through arginine supplementation
Observe the change in T cell functional response
Measured: Study days 0 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completion6 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allen Waziri, MD, Principal investigator, Inova Health Care Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017249
- Sponsor's protocol ID
- 13-1364
- Acronym
- ArginineGBM
- Status last verified
- May 2018
- First submitted
- 7 Nov 2013
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02017249
- Acronym / sponsor ID
- ArginineGBM / 13-1364
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- 6 Oct 2015 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arginine | Experimental | Drug: arginine in powder form24.15g 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 | Drug: Silica and cellulose placebo powder3.5 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arginine in powder form | Drug | Arginine |
| Silica and cellulose placebo powder | Drug | Silica and cellulose placebo powder |
Primary outcome
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
Change in control group immune function through arginine supplementation
Time frame: Study days 0 and 8
Observe the change in T cell functional response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen Waziri, MD principal investigator
Inova Health Care Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing arginine in powder form in people with Glioblastoma Multiforme, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GBM patients immune function through arginine supplementation (time frame: study day 0 and 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.