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ONC206 + Radiation Therapy for Brain Tumor (PNOC023 Trial)
PNOC023 Trial Summary
This trial is studying the effects and best dose of ONC206 given alone or with radiation therapy in treating patients with newly diagnosed or recurrent diffuse midline gliomas or other recurrent primary malignant CNS tumors.
PNOC023 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPNOC023 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PNOC023 Trial Design
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Who is running the clinical trial?
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- I have an immune system disorder like HIV, hepatitis B or C, or an autoimmune disease.I do not have any infections that are currently uncontrolled.I have been on a stable or decreasing dose of steroids for at least 3 days before my baseline MRI scan.I have recovered from all side effects of my previous treatments.My child has a recurring brain tumor that has progressed but hasn't been treated for this progression.You are currently using illegal drugs or have been diagnosed with alcoholism.You are currently taking other medications for cancer.I do not have conditions that affect drug absorption.I have no lingering side effects from my previous treatments.My tumor tissue has been collected for testing.I am a child or young adult with DMG, H3K27 altered cancer, have completed at least one treatment line including radiation, and it's been 4-14 weeks since my last radiation therapy.I am a child or young adult with a progressing DMG and haven't been treated for this progression, but re-irradiation is recommended.My tumor is not located in the brainstem or spinal cord.My kidney function, measured by creatinine, is within the normal range for my age and gender.I haven't taken strong enzyme affecting drugs for 14 days and won't during the study.I am mostly able to care for myself and carry out daily activities.I am newly diagnosed with a specific brain tumor showing certain genetic changes.Your bilirubin levels must be within a certain range, depending on your age and health condition. If you have Gilbert's syndrome, there are different limits for your bilirubin levels.I had focal radiation therapy over 6 months ago as part of my initial treatment.I am willing to provide tissue samples for the study.My previous tests confirmed I have a malignant brain tumor.I am pregnant or breastfeeding.You have had allergic reactions to drugs similar to ONC206.Your liver enzyme levels are not more than three times the normal limit.Your AST levels are not more than three times the normal upper limit.My platelet count is healthy without needing a transfusion in the last week.Your blood test shows you have enough infection-fighting white blood cells.My tumor is confirmed as DMG, H3K27 altered by a pathology test.My tumor is confirmed to have a specific genetic change known as DMG, H3K27 altered.I have recovered from all side effects of my previous treatments.I am a young person newly diagnosed with a specific brain or spinal tumor.My child has a recurring brain tumor that has worsened but hasn't been treated yet.You have a seizure disorder that is well-managed.
- Group 1: Arm D: ONC206 Therapy, Primary malignant CNS tumors with progression
- Group 2: Arm B: ONC206 + radiation therapy for newly diagnosed participants
- Group 3: Arm A: ONC206 for participants with diffuse midline gliomas + prior therapy
- Group 4: Arm C: ONC206 + radiation therapy, DMGs with evidence of first progression but previously untreated
- 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
Are there any antecedent tests involving ONC206?
"ONC206 was initially studied in 2011 at Valme University Hospital, with 65 studies since completed. Currently 14 active trials are underway throughout the world, particularly in San Francisco, California."
What conditions typically respond favorably to ONC206 treatments?
"ONC206 is frequently used to address hypotension caused by trauma, sepsis, cardiac surgery and renal failure as well as illnesses such as myocardial infarction, cystic fibrosis (cf) and arrhythmia."
What efficacy goals is this trial hoping to accomplish?
"This medical experiment intends to observe the frequency of dose-limiting toxicities (DLT) during a 4 week period post first dosage. Secondary objectives include analyzing the mean total body clearance, peak concentration time, and area under curve for ONC206 through population PK methodologies as well as non-linear mixed effect modeling."
How many individuals are participating in this medical trial?
"Correct. According to clinicaltrials.gov, this trial is still open for recruitment and was last updated on September 13th 2022; it first appeared online on August 23rd 2021. A total of 256 patients need to be enrolled across two medical centres."
Does this empirical inquiry encompass elderly participants aged 85 or more?
"According to the eligibility parameters, only patients between 2 and 21 years old are allowed to join this trial. On a larger scale, 572 trials target minors while 3754 clinical studies encompass people older than 65."
Is enrollment for this clinical experiment still available to participants?
"According to clinicaltrials.gov, this medical experiment is actively in search of volunteers and was first publicized on August 23rd 2021 with an update occurring one year later."
Has this specific trial been conducted before in medical history?
"Research into the benefits of ONC206 has been ongoing since 2011, when Boehringer Ingelheim first sponsored a trial involving 60 patients. This study resulted in N/A approval for the medication and today there are 14 active studies with locations spanning 43 cities across 15 countries."
What adverse effects could patients encounter from ONC206 treatments?
"The safety profile of ONC206 is rated at 1 due to the limited clinical data available from its Phase 1 trials, which provide little information on efficacy and safety."
What are the eligibility criteria for taking part in this research?
"This clinical trial seeks 256 young patients ranging from 2 to 21 suffering from glioblastoma. All participants must meet the following criteria: Arm A- Patients who have completed at least one line of prior therapy, including radiation and cannot show evidence of disease progression; Arm B- Newly diagnosed sufferers with a confirmed diagnosis or DMG (H3K27M mutant) or WHO grade III/IV H3 wildtype gliomas; Arm C- Suffers that are experiencing an initial relapse but has not been treated yet and is recommended for reirradiation. Additionally, all arms need to be free of acute effects caused by"
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