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Selinexor + Radiation for Brain Cancer
Phase 1 & 2
Waitlist Available
Led By Adam L Green
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to step 1 enrollment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of selinexor in combination with radiation therapy in treating children and young adults with newly diagnosed brain cancer.
Who is the study for?
This trial is for children and young adults aged 1 to 21 with newly-diagnosed DIPG or HGG that have a specific genetic mutation (H3 K27M). They must be able to breathe without difficulty, not pregnant or breastfeeding, willing to use birth control if applicable, and have not received prior cancer treatment except surgery. Patients should also have normal organ function.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Selinexor combined with standard radiation therapy on brain tumors in two phases: finding the highest dose patients can take without severe side effects (Part 1), then seeing how well this dose works against the tumors (Part 2).See study design
What are the potential side effects?
Selinexor may cause fatigue, nausea, loss of appetite, blood count changes, and other symptoms related to its effect on protein blocking in cancer cells. Radiation therapy might lead to skin irritation at the treated site, tiredness, headaches depending on where it's applied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by creatinine clearance or GFR, is good.
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I am a woman able to have children and have a negative pregnancy test.
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I am between 12 and 21 years old.
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I have been recently diagnosed with a specific type of brain tumor.
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My bilirubin levels are within the normal range for my age.
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I am not pregnant.
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I am newly diagnosed with a high-grade glioma or have DIPG.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event free survival (EFS)
Maximum tolerated dose
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (selinexor and radiation therapy)Experimental Treatment4 Interventions
CHEMORADIOTHERAPY: Patients receive standard of care radiation therapy 5 days per week for 5-7 weeks. Starting on day 4 or 5 of radiation therapy, patients receive selinexor PO on 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. After a 2-week rest period, patients proceed to Maintenance. Patients undergo a MRI and may undergo a biopsy during screening.
MAINTENANCE: Patients receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 24 cycles of maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients undergo a MRI on study and during follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Biopsy
2014
Completed Phase 4
~850
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,943 Total Patients Enrolled
17 Trials studying Diffuse Intrinsic Pontine Glioma
865 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Adam L GreenPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not breastfeeding or have agreed to stop while on the trial.My age fits the pre-screening criteria for high-grade glioma patients.I can take care of myself but might not be able to do heavy physical work.I have only had surgery and steroids for my brain cancer.I have macular degeneration, uncontrolled glaucoma, or cataracts.I am 18 or older with a specific type of brain tumor that is not H3 K27M-mutant.My kidney function, measured by creatinine clearance or GFR, is good.I am between 12 months and 21 years old.I don't have shortness of breath at rest, can exercise, and my oxygen levels are above 94%.I do not have cancer that has spread to other parts of my body.I am suspected to have a new high-grade glioma or have been diagnosed with DIPG.I do not have gliomatosis cerebri, but I may have a specific type of brain tumor with a H3 K27M mutation.My platelet count is at least 100,000 without needing a transfusion.I have seizures but they are well controlled with medication.I am a woman able to have children and have a negative pregnancy test.I am between 12 and 21 years old.I have been recently diagnosed with a specific type of brain tumor.My hemoglobin level is at least 8.0 g/dL.My bilirubin levels are within the normal range for my age.I cannot undergo the specific radiation therapy outlined in the study.I am not pregnant.I do not have any infections that are currently uncontrolled.I am newly diagnosed with a high-grade glioma or have DIPG.I don't have shortness of breath at rest, can exercise, and my oxygen levels are above 94%.I have a movement disorder that is moderate to severe.I have a high-grade glioma that is not spread or I have a diagnosis of DIPG.I am under 18 or my tumor has an H3K27M mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selinexor and radiation therapy)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians admissible to this research project?
"This study's age bracket for participants is 12 months to 21 years old."
Answered by AI
What is the scientific research community's opinion of Radiation Therapy?
"The first recorded study of radiation therapy occurred in 2014 at Princess Margaret Cancer Centre. As of now, there have been 230 completed studies with 49 active trials taking place. A large concentration of these ongoing studies are based in Louisville, Kentucky."
Answered by AI
Is it possible to still enroll in this clinical trial?
"That is accurate, the online information does show that this research is actively looking for study subjects. It was first advertised on May 5th, 2022 and had some changes made to it on November 8th of the same year. They are looking for 210 patients total from 48 different locations."
Answered by AI
Who is eligible to participate in this clinical trial?
"This clinical trial is seeking out 210 individuals aged 12 months to 21 years old that have been diagnosed with glioblastoma. There are a few key eligibility requirements that potential patients must meet, which are as follows: being between the ages of 12 months and 21 years old at the time of enrollment on Step 0 (this age range includes pre-screening for all HGG patients), having signed informed consent for eligibility screening on APEC14B1 Part A, or having signed informed consent for ACNS1821. In addition, specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14"
Answered by AI
Who else is applying?
What site did they apply to?
UCSF Medical Center-Mission Bay
What portion of applicants met pre-screening criteria?
Did not meet criteria
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