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Clinical Trials: A Randomized Placebo-Controlled Trial Exploring the Efficacy of Oral Arginine to Improve Cellular Immune Function in Patients with Glioblastoma Multiforme

 


A Randomized Placebo-Controlled Trial Exploring the Efficacy of Oral Arginine to Improve Cellular Immune Function in Patients with Glioblastoma Multiforme


Trial Focus

Trial Focus

Brain & Nervous System

Objective

        
The purpose of this study is to learn more about the ability of a substance known as Arginine to improve the function of the immune system in people with a certain type of brain tumor – Glioblastoma Multiforme. This could lead to improvements in a type of treatment for brain tumors called “immunotherapy”. 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 pill form will make their immune systems

IRB Protocol #

11-0750

Trial Status

In Progress

Contact

Marci Klaassen PA at 303-724-2397 or marci.klaassen@ucdenver.edu

Eligibility and Other Participant Information


What To Expect: Following a brief screening period after the initial diagnosis of Glioblastoma Multiforme to determine your eligibility, the active study participation lasts for 2 to 3 weeks. At your pre-operative exam 7 days before planned surgery you will have a blood draw (2-3 tablespoons) and a health questionnaire before starting taking the study supplement, and will then be taking 6 study pills 4 times a day for 7 days. During surgery a small sample of the resected tumor will be taken for research purposes. No additional biopsies will be necessary. After surgery, when you are able, you will restart the study pills and will continue to take 6 pills 4 times a day for 7 to 10 days after surgeryyou’re your post-operative exam 7-10 days after surgery you will have another blood draw (2-3 tablespoons). At this point you will complete the study participation.