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Selinexor + Radiation for Brain Cancer
Phase 1 & 2
Recruiting
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)
Must not have
Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid medications
Patients with known macular degeneration, uncontrolled glaucoma, or cataracts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the safety and effectiveness of combining selinexor with radiation therapy in children and young adults with aggressive brain tumors. Selinexor is a drug that blocks a protein to stop cancer cells from growing. The study aims to find the best dose and see if this combination can shrink tumors.
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.
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).
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have only had surgery and steroids for my brain cancer.
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I have macular degeneration, uncontrolled glaucoma, or cataracts.
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I am 18 or older with a specific type of brain tumor that is not H3 K27M-mutant.
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I do not have cancer that has spread to other parts of my body.
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I cannot undergo the specific radiation therapy outlined in the study.
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I do not have any infections that are currently uncontrolled.
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I have a movement disorder that is moderate to severe.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event free survival (EFS)
Maximum tolerated dose
Overall Survival (OS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
Biopsy
2014
Completed Phase 4
~1150
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Radiation Therapy
2017
Completed Phase 3
~7250
Selinexor
2020
Completed Phase 3
~1730
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
The most common treatments for Diffuse Intrinsic Pontine Glioma (DIPG) include selinexor and radiation therapy. Selinexor works by inhibiting the CRM1 protein, which disrupts the export of tumor suppressor proteins from the nucleus, thereby preventing cancer cell growth and inducing cell death.
Radiation therapy, on the other hand, uses high-energy radiation to directly kill tumor cells and shrink tumors. These mechanisms are crucial for DIPG patients because this type of glioma is highly aggressive and located in a critical area of the brain, making it difficult to treat.
By combining selinexor's ability to inhibit cancer cell growth with radiation's tumor-killing effects, there is potential for improved treatment efficacy and patient outcomes.
A Phase II Study of the Efficacy and Safety of Oral Selinexor in Recurrent Glioblastoma.How did lomustine become standard of care in recurrent glioblastoma?The XPO1 Inhibitor Selinexor Inhibits Translation and Enhances the Radiosensitivity of Glioblastoma Cells Grown <i>In Vitro</i> and <i>In Vivo</i>.
A Phase II Study of the Efficacy and Safety of Oral Selinexor in Recurrent Glioblastoma.How did lomustine become standard of care in recurrent glioblastoma?The XPO1 Inhibitor Selinexor Inhibits Translation and Enhances the Radiosensitivity of Glioblastoma Cells Grown <i>In Vitro</i> and <i>In Vivo</i>.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,955 Previous Clinical Trials
41,111,741 Total Patients Enrolled
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.