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Stress Response Inducer
ONC206 + Radiation Therapy for Brain Tumor (PNOC023 Trial)
Phase 1
Recruiting
Research Sponsored by Sabine Mueller, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TARGET VALIDATION: Children and young adults with recurrent primary malignant CNS tumors, including recurrent DMG, who have evidence of progression but have not been treated for this progression
Serum creatinine < 1.5 Upper Limit normal (ULN) based on age and gender
Must not have
Participants with a known disorder that affects their immune system, such as HIV, hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy
Participants with uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)
Awards & highlights
Summary
This trial studies the effects of ONC206, a new drug that stresses out cancer cells to kill them, in children and young adults with difficult-to-treat brain tumors. The drug can be used alone or with radiation therapy. ONC206 is related to ONC201, which has shown promise in treating certain types of brain tumors.
Who is the study for?
This trial is for children and adults with newly diagnosed or recurrent diffuse midline gliomas (DMG) and other malignant CNS tumors. Participants must have stable vital signs, not be pregnant or breastfeeding, agree to use contraception if applicable, and cannot be on certain medications that affect ONC206 absorption or immune system disorders.
What is being tested?
The trial is testing the effectiveness of a new drug called ONC206 alone or combined with standard radiation therapy. The goal is to find the best dose that can stop tumor growth by triggering a stress response in cancer cells without harming normal cells.
What are the potential side effects?
Potential side effects of ONC206 are not detailed here but may include reactions related to the body's stress response to treatment. Standard radiation therapy side effects typically include fatigue, skin irritation at the treatment site, and potential hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has a recurring brain tumor that has progressed but hasn't been treated for this progression.
Select...
My kidney function, measured by creatinine, is within the normal range for my age and gender.
Select...
I am newly diagnosed with a specific brain tumor showing certain genetic changes.
Select...
I am willing to provide tissue samples for the study.
Select...
My previous tests confirmed I have a malignant brain tumor.
Select...
My tumor is confirmed as DMG, H3K27 altered by a pathology test.
Select...
My tumor is confirmed to have a specific genetic change known as DMG, H3K27 altered.
Select...
I am a young person newly diagnosed with a specific brain or spinal tumor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an immune system disorder like HIV, hepatitis B or C, or an autoimmune disease.
Select...
I do not have any infections that are currently uncontrolled.
Select...
I haven't taken strong enzyme affecting drugs for 14 days and won't during the study.
Select...
I am pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), day 3 (pre-dose, 0.5, 1, 2, 4, 8 post-dose), (2 days in total)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD) of ONC206
Proportion of participants with dose-limiting toxicities (DLT)
Secondary study objectives
Area under the curve (AUC) of ONC206
Elimination half-life (t1/2) of ONC206
Mean Total body clearance (CL) for ONC206
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Arm D: ONC206 Therapy, Primary malignant CNS tumors with progressionExperimental Treatment2 Interventions
Patients receive ONC206 PO once a day (QD) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm C: ONC206 + radiation therapy, DMGs with evidence of first progression but previously untreatedExperimental Treatment3 Interventions
Patients undergo standard of care radiation therapy daily 5 days a week and receive ONC206 PO up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group III: Arm B: ONC206 + radiation therapy for newly diagnosed participantsExperimental Treatment3 Interventions
Patients undergo standard of care radiation therapy daily 5 days a week and receive ONC206 PO up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Group IV: Arm A: ONC206 for participants with diffuse midline gliomas + prior therapyExperimental Treatment2 Interventions
Patients receive ONC206 orally (PO) up to six times per week. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Diffuse Midline Glioma include radiation therapy and emerging targeted therapies like ONC206. Radiation therapy works by damaging the DNA of cancer cells, leading to cell death and slowing tumor growth.
ONC206, a novel compound, induces a stress response in tumor cells, causing them to die without affecting normal cells. This mechanism is crucial for Diffuse Midline Glioma patients as it offers a targeted approach that minimizes damage to healthy brain tissue, potentially improving outcomes and reducing side effects compared to traditional therapies.
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,103 Previous Clinical Trials
359,224 Total Patients Enrolled
The ChadTough Defeat DIPG FoundationUNKNOWN
Storm the Heavens FundUNKNOWN
1 Previous Clinical Trials
360 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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