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Telaglenastat + Radiation Therapy + Temozolomide for Astrocytoma
Study Summary
This trial is testing a combination of telaglenastat, radiation therapy, and chemotherapy in treating patients with brain tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer has a specific IDH mutation.I am on a stable blood thinner dose without bleeding or clotting issues.I have never used Gliadel wafers.I am not pregnant or breastfeeding.I have not had radiation therapy to my brain or overlapping areas of my head and neck.I do not have an active cancer other than non-melanoma skin cancer, or I have been free of any other cancer for over 3 years.I had hepatitis C but have been treated and now have no detectable virus.It has been over a week since my stereotactic biopsy or over two weeks since my open craniotomy.My steroid dose has been stable or decreasing for the last week.My epilepsy medication dose has been stable or reduced in the last 14 days.I have chronic hepatitis B but it's under control or undetectable.I am not pregnant, will use birth control during the study, and will notify if pregnancy occurs.I have another cancer type, but it won't affect this cancer treatment's safety or results.My heart function is classified as class 2B or better, despite my history of cardiac issues or treatments.I am mostly self-sufficient and can carry out daily activities.My cancer has not spread to my brain's lower part or spine.I have issues that could affect how my body absorbs pills, like constant vomiting or past stomach surgery.I have not had chemotherapy for my brain tumor.I have HIV but it's undetectable due to effective treatment.I primarily speak English, which is needed for the study's tests.I do not have any unmanaged ongoing illnesses.I am 16 years old or older.I cannot swallow pills.My kidney function, measured by creatinine levels or clearance, is within the normal range.I am a young person who needs sedation for MRI or MRS scans.I am allergic to medications similar to telaglenastat or TMZ.
- Group 1: Treatment (telaglenastat, temozolomide, RT)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many of the research sites for this study are located in Canada?
"At the moment, there are 7 sites participating in this clinical trial. These locations include Oklahoma City, Baltimore and Salt Lake City along with other cities around them. It is recommended that participants select a clinic close to their residence so as to minimize travelling costs should they choose to enroll."
Has the FDA sanctioned Radiation Therapy for therapeutic purposes?
"As this is an experimental trial with only limited data regarding its safety and efficacy, Radiation Therapy received a score of 1."
What other investigations have been conducted concerning the application of Radiation Therapy?
"At this time, 212 Radiation Therapy trials are in progress with 23 of those being Phase 3. While these studies primarily exist within Seoul and Songpa, there is a total of 4802 sites that specialize in researching radiation therapy treatments."
Is this trial an unprecedented endeavor in the field of medicine?
"The exploration of Radiation Therapy began in 2002 with a Schering-Plough sponsored clinical trial. Following the successful completion of that 60 patient study, Phase 2 drug approval was granted and prompted 212 active trials to be conducted across 940 cities located in 36 countries."
How many participants are actively engaging in this research project?
"This research study is no longer accepting participants, as the last update was on October 19th 2022. There are plenty of alternative trials to consider if you have astrocytoma: 82 studies that need volunteers and 212 for those interested in Radiation Therapy."
What maladies typically require radiation treatments?
"Radiation Therapy is predominantly utilised to treat nitrosourea treatment, yet can also be used in the management of advance directives, refractory mycosis fungoides, and difficult cases of neuroblastoma."
Is recruitment for this research still in progress?
"As stated on clinicaltrials.gov, this trial is no longer actively recruiting patients since it was last updated in October of 2022. Despite that, there are 294 other trials at the present time looking for participants to join their studies."
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