Selinexor for Pediatric Solid Tumors or Brain Tumors

Recruiting at 23 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Children's Oncology Group

Must not be taking: Corticosteroids, Investigational drugs, Anti-cancer agents

Disqualifiers: Pregnancy, Uncontrolled infection, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 24 months

59 Participants Needed

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.

Research Team

Julia Glade-Bender

Principal Investigator

COG Phase I Consortium

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

Exclusion Criteria

Patients with prior solid organ transplantation

I have severe unsteadiness or movement disorders.

I have macular degeneration, uncontrolled glaucoma, or cataracts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive selinexor orally on a twice weekly or once weekly schedule. Treatment repeats every 28 days for up to 24 cycles.

Up to 24 months

Visits on days 1, 3, 8, 10, 15, 17 or days 1, 8, 15, 22 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days

Treatment Details

Interventions

• Selinexor

Trial Overview 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.

Participant Groups

Group I: Treatment (selinexor) Experimental Treatment 2 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:

• Multiple myeloma
• Diffuse large B-cell lymphoma

Approved in Canada as Xpovio for:

• Multiple myeloma

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+