RecruitingPhase 2NCT05985161

A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors

A Multi-Center Phase II Study of Selinexor in Treating Recurrent or Refractory Wilms Tumor and Other Pediatric Solid Tumors

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

45 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Solid Tumor Wilms Tumor Rhabdoid Tumor Malignant Peripheral Nerve Sheath Tumors Nephroblastoma MPNST XPO1 Gene Mutation

Summary

The purpose of this study is to find out whether selinexor is an effective treatment for people who have a relapsed/refractory Wilms tumor, rhabdoid tumor, MPNST, or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes that increase the activity of XP01.

Eligibility

Min Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This study is testing selinexor, a drug that blocks cancer cells from exporting key proteins, in children and young adults with Wilms tumors (a kidney cancer) and other solid tumors that have relapsed or are hard to treat. **You may be eligible if:** - You are at least 12 months old - You have a Wilms tumor (nephroblastoma) that has relapsed more than once, or has high-risk features, or has not responded to multiple prior treatments - You have another eligible solid tumor type (such as rhabdoid tumor, desmoplastic small round cell tumor, or others listed in the trial) - You are able to participate in study activities (Karnofsky/Lansky score ≥60%) **You may NOT be eligible if:** - You have active or uncontrolled central nervous system disease - You have serious organ dysfunction that makes treatment unsafe - You are pregnant or breastfeeding - You cannot take oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor

This phase II study will initially treat all patients, including adult patients, at the pediatric Selinexor RP2D of 35 mg/m2 (no maximum dose) once weekly using a liquid suspension .

Locations(16)

Children's Hospital of Los Angeles (Data Collection Only)

Los Angeles, California, United States

Stanford Medicine Children's Health (Data Collection Only)

Palo Alto, California, United States

Children's National Hospital (Data Collection Only)

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta (Data Collection and Specimen Analysis)

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children'S Hospital of Chicag

Chicago, Illinois, United States

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Cincinnati Children's Hospital Medical Center (Data collection only)

Cincinnati, Ohio, United States

Cook Children's Health Care System (Data Collection Only)

Fort Worth, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05985161

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