Selinexor for Pediatric Solid Tumors or Brain Tumors

Recruiting in Palo Alto (17 mi)

+23 other locations

Overseen ByJulia Glade-Bender

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system (CNS) tumors that have come back (recurrent) or do not respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility Criteria

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.

Inclusion Criteria

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

Patients must meet specific blood count criteria

Patients must be able to swallow tablets whole

+12 more

Exclusion Criteria

Patients with prior solid organ transplantation

I have severe unsteadiness or movement disorders.

I have macular degeneration, uncontrolled glaucoma, or cataracts.

+6 more

Participant Groups

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.

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.

Selinexor is already approved in United States, Canada for the following indications:

🇺🇸 Approved in United States as Xpovio for: