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ONC206 for Gliomas(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.
- Diffuse Midline Glioma
- Brain Tumor
- Spinal Cord Glioma
PNOC023 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
PNOC023 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
PNOC023 Trial Design
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Who is running the clinical trial?
- You are currently taking other medications for cancer.You have a condition that might make it hard for your body to absorb ONC206.Your blood test shows you have enough infection-fighting white blood cells.You are not eligible if your tumor did not start in the brainstem or spinal cord.You are willing to provide enough tissue for the study.You have had allergic reactions to drugs similar to ONC206.For group A, it is required to confirm the type of tumor by testing the tissue for specific genetic changes.You need to have a tissue sample from your tumor that shows it is a specific type called DMG with a certain genetic change.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.You have a condition that weakens your immune system, like HIV, hepatitis B or C, or an autoimmune disorder needing strong treatment.You have an infection that is not being controlled.You are currently using illegal drugs or have been diagnosed with alcoholism.Children and young adults with a certain type of brain tumor showing signs of getting worse, who have not yet received treatment for this worsening, and are advised to have radiation therapy again.Children and young adults with a specific type of brain tumor who have received treatment in the past, including radiation therapy, and are within 4-14 weeks from completing radiation therapy.Children and young adults who have been recently diagnosed with a specific type of brain tumor called DMG with a specific genetic change are eligible. This also includes DMGs in the spinal cord.You have had targeted radiation treatment as part of your initial therapy, and it has been at least 6 months since your last radiation treatment.Children and young adults with recurring brain tumors that have started growing again and have not received treatment for this growth.You need to have had a previous test to confirm that your tumor is in the brain, and the results should show that it is cancerous.People with newly discovered brain tumors that show certain changes in their DNA are allowed to join the study.Children and young adults with recurring brain tumors who have not received treatment for their latest progression.If you are taking steroids, the dose should not be increasing for at least 3 days before the MRI scan.Your platelet count is at least 100 billion per liter of blood, and you have not needed a blood transfusion for at least 7 days before joining the study.Your kidney function, as measured by a blood test, should be within a certain range based on your age and gender.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.You have a seizure disorder that is well-managed.If you are older than 16, your Karnofsky score needs to be at least 50. If you are 16 or younger, your Lansky score needs to be at least 50.
- 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, 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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