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Selective Inhibitor of Nuclear Export (SINE)

Selinexor for Pediatric Solid Tumors or Brain Tumors

Phase 1

Waitlist Available

Led By Julia Glade-Bender

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with recurrent or refractory high grade glioma (WHO grade III/IV) are eligible if they meet specific criteria

Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age

Must not have

Patients with grade 3 ataxia or grade >1 extrapyramidal movement disorder

Patients with known macular degeneration, uncontrolled glaucoma, or cataracts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years 11 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies selinexor to learn if it can help to shrink tumors in young patients with solid tumors or CNS tumors.

Who is the study for?

This trial is for young patients with solid tumors or high-grade gliomas that have returned or are not responding to treatment. They must be able to swallow tablets, have a body surface area (BSA) >= 0.84 m^2, and meet specific blood count and organ function criteria. Not eligible if they've had selinexor before, are pregnant/breastfeeding, on investigational drugs, have uncontrolled infections or certain medical conditions.

What is being tested?

The trial is testing the safety and optimal dosage of a chemotherapy drug called Selinexor in younger patients. This medication aims to stop tumor growth by killing cells or preventing them from dividing and spreading.

What are the potential side effects?

Selinexor may cause side effects such as nausea, vomiting, fatigue, loss of appetite, weight loss, diarrhea, changes in blood counts leading to increased risk of infection or bleeding problems; neurological symptoms like dizziness; mood changes; liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is a high-grade, aggressive brain tumor that has returned or didn't respond to treatment.

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I am mostly able to care for myself and carry out daily activities.

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My body surface area is at least 0.84 square meters.

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I have never been treated with selinexor.

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My current condition cannot be cured with existing treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe unsteadiness or movement disorders.

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I have macular degeneration, uncontrolled glaucoma, or cataracts.

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I am not on a stable dose of corticosteroids.

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I do not have any infections that are currently uncontrolled.

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My BMI is below the 3rd percentile for my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years 11 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Drug Concentration Curve of Selinexor

Number of Adverse Events of Selinexor

Number of Dose Limiting Toxicities of Selinexor

Secondary study objectives

Antitumor Effect of Selinexor

Pharmacodynamics of Selinexor

Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients

+2 more

Awards & 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)Experimental Treatment2 Interventions

Patients receive selinexor PO on either a twice weekly (days 1, 3, 8, 10, 15, 17) or once weekly (days 1, 8, 15, and 22) schedule. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selinexor

2020

Completed Phase 3

~1730

0 / 10Eligibility criteria met