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Study Summary
This trial is testing a new drug, ONC201, for its safety and effectiveness in treating brain tumors in children. The trial will have 7 different arms, testing different aspects of the drug.
- Malignant Glioma
- Diffuse Intrinsic Pontine Glioma
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 30 Patients • NCT03394027Trial Design
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- You have been recently diagnosed with a brain tumor called diffuse intrinsic pontine glioma (DIPG), whether or not it has been confirmed by a biopsy.You are currently using illegal drugs or have been diagnosed with alcoholism.You have had an allergic reaction to ONC201 or its ingredients in the past.You are between 2 and 18 years old.If you have a specific type of brain tumor called midline glioma, you can join the study with or without biopsy confirmation as long as the site investigator approves.You are able to easily swallow and keep down capsules by mouth.You have received treatment with ONC201 before.You must have waited a certain amount of time since your last treatment before starting the study: 5 times the half-life of any experimental drug, 4 weeks from most chemotherapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibody treatment, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor treatments. If you have had radiation therapy, you must wait at least 2 weeks after local palliative radiotherapy. For one of the study arms, you must wait at least 90 days from prior radiation, unless the progressive lesion is outside of the high-dose radiation target volume or there is unequivocal evidence of progressive tumor on a biopsy specimen.You must weigh enough to receive the dose of ONC201 required for the study. The minimum weight requirement ranges from 10-27.5kg, depending on the dose level.You have glioma and a specific mutation in your H3 K27M genes. You have received at least one prior therapy, but evidence of progression is not required. You have had no more than two recurrences from radiotherapy and/or chemotherapy. If your tumor's H3 K27M status is unknown and archival tumor tissue is not available, a post-mortem biopsy is required.You have a type of brain tumor called diffuse intrinsic pontine glioma (DIPG) that is located in the pons region of the brain, with or without confirmation through a biopsy. If the tumor's H3 K27M status is unknown and there is no available previous biopsy, a biopsy may be required after death.You have a type of brain tumor called midline glioma, and you may or may not have had a biopsy to confirm the diagnosis. You may be eligible to participate in this trial.You are currently involved in or planning to participate in another study involving experimental drugs or devices.You have a medical or mental health condition that is not under control or a social situation that may make it difficult to follow the study requirements.You have a specific type of brain tumor called recurrent glioma with a certain genetic mutation. You have already received at least one prior treatment, and you must be willing to have multiple spinal tap procedures and sedated MRIs. You do not need to show evidence of tumor growth to receive the study medication, and you cannot have had more than two recurrences of the tumor after prior treatment. If you have signs of elevated intracranial pressure such as worsening headaches or sleepiness, you cannot have the spinal tap procedure.You have a specific type of brain tumor called glioma with a certain mutation (H3 K27M) or a subtype of glioma called diffuse intrinsic pontine glioma (DIPG). You must have completed your first round of radiation treatment between 2-12 weeks ago. It is okay if the tumor has not gotten worse so that you can receive ONC201 as a maintenance treatment or if the tumor has come back.Children with a specific type of brain tumor called high-grade glioma are eligible if they have a genetic mutation called histone H3 K27M. The tumor must have gotten worse since their last MRI scan and they must have had radiation therapy before.You are able to perform daily activities on your own without much help, and for younger patients, you are able to carry out age-appropriate tasks without much assistance.
- Group 1: Dose Expansion Cohort in relapsed/refractory H3 K27M glioma
- Group 2: ONC201 in newly diagnosed DIPG
- Group 3: H3 K27M CSF Biopsy
- Group 4: Liquid ONC201 in relapsed/refractory H3 K27M glioma
- Group 5: Midline Glioma Biopsy
- Group 6: ONC201 in relapsed/refractory H3 K27M glioma
- Group 7: ONC201 given on two consecutive days of each week
- 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 individuals are actively engaging with this research?
"Unfortunately, no further patients are being taken on for this trial. It was initially posted in January 2018 but the last update to its information occurred November 8th 2022. If you're searching for alternative studies, there currently exist 362 clinical trials actively accepting participants with diffuse intrinsic pontine glioma and 9 research efforts recruiting patients receiving ONC201 treatment."
Does the age limitation of this trial extend below fifty years?
"As indicated by the inclusion criteria, this medical trial is open to children aged 2-18. In total, there are 389 clinical trials available for people under 65 years of age."
Is enrollment still open for this research endeavor?
"This research is no longer enrolling participants, as it was last edited on November 8th 2022. However, if you are seeking other trials for diffuse intrinsic pontine glioma there are currently 362 open studies and 9 ONC201 related clinical trials accepting patients."
How many medical facilities are participating in this experiment?
"MD Anderson Cancer Center in Houston, Texas, Children's Healthcare of Atlanta, Emory University School of Medicine in Atlanta and Cincinnati Children's Hospital Medical Center are several sites where this trial is currently taking place. In addition to these locations, there are seven other medical centres participating as well."
Has this research ever been done before?
"Since 2015, ONC201 has been the subject of multiple clinical trials. The initial research was funded by Oncoceutics Inc., and following successful Phase 1 & 2 results, 9 live studies are currently being conducted in 28 cities across 4 countries."
Are there precedents for utilizing ONC201 in clinical studies?
"Currently, there are 9 active trials for the drug ONC201 with none of them in Phase 3. Though most studies involving this medication happen to be located around Salt Lake City, UT, a total of 48 sites administer clinical trials on it."
What adverse effects have been observed with the use of ONC201?
"Due to the preliminary nature of this trial, ONC201's safety rating is a 1. This means that there are only limited data sets demonstrating its efficacy and potential for harm reduction."
Who is eligible to sign up for this medical experiment?
"This medical trial is looking to recruit 130 participants aged between 2 and 18 with diffuse intrinsic pontine glioma. These applicants must meet certain criteria, including a body weight of at least 10kg for the lowest dose level or 27.5kg for the highest, positivity for H3 K27M mutations in CLIA laboratory tests and willingness to undergo serial lumbar punctures. Additionally, those with recurrent cancers may not have had more than two prior episodes of recurrence from radiotherapy/chemotherapy and need to be at least five half-lives after any investigational agents before enrolling. Finally, those receiving radiation"
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