Actively Recruiting
A Multi-Center Phase II Study of Selinexor in Treating Recurrent or Refractory Wilms Tumor and Other Pediatric Solid Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-06
45
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating selinexor as a potential treatment for people with relapsed or refractory Wilms tumor, rhabdoid tumor, malignant peripheral nerve sheath tumors (MPNST), BCOR-driven sarcomas, or other solid tumors that produce higher than normal levels of the XPO1 protein or have genetic changes that increase XPO1 activity. This phase II study aims to understand selinexor's effectiveness in these specific pediatric solid tumors, sponsored by Memorial Sloan Kettering Cancer Center. The study treats participants with selinexor at a pediatric recommended phase 2 dose of 35 mg/m2 once weekly using a liquid form, with a maximum dose of 100 mg per dose. Participants are divided into cohorts based on their tumor type, including Wilms tumor, rhabdoid tumor, MPNST, other solid tumors showing potential benefit from selinexor, and BCOR-driven sarcomas. Each cohort follows the same treatment schedule, and some patients may be enrolled in pharmacokinetic cohorts depending on their age. During the study, participants will undergo assessments to monitor their disease status, including measurable disease evaluations using standardized criteria. Researchers will track the overall response rate six months after treatment begins to determine the treatment's impact. Participants must meet specific health criteria, including adequate organ function and performance status. The study includes informed consent, safety monitoring, and follows participants until the end of the treatment period, which may last several months.
CONDITIONS
Brief Title
A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 months or older at the time of informed consent
- Signed informed consent by patient or legal representative; assent when appropriate
- Karnofsky score 60% or higher if over 16 years old; Lansky score 60 or higher if 16 years or younger
- Diagnosis of Wilms tumor, rhabdoid tumor, MPNST, other solid tumor with evidence for selinexor benefit, or BCOR-driven sarcoma
- Measurable disease for phase II patients; evaluable or measurable disease for PK cohorts
- Failed at least one prior systemic therapy
- Adequate hepatic, renal, and hematologic function within 14 days before treatment
- Agreed to use two effective birth control methods if of reproductive potential during study
You will not qualify if you...
- Previous treatment with selinexor or another XPO1 inhibitor
- Uncontrolled infection
- Prior solid organ transplant
- Inability to comply with study requirements due to medical, psychiatric, or social reasons
- Pregnant or breastfeeding women
- Active treatment for graft-versus-host disease after allogeneic bone marrow transplant
- Participation without agreeing to required contraception if of reproductive potential
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive Selinexor once weekly using a liquid suspension at the pediatric recommended phase 2 dose.
Weekly visits for up to 6 months
Trial Site Locations
Total: 16 locations
1
Children's Hospital of Los Angeles (Data Collection Only)
Los Angeles, California, United States, 90027
Actively Recruiting
2
Stanford Medicine Children's Health (Data Collection Only)
Palo Alto, California, United States, 94304
Actively Recruiting
3
Children's National Hospital (Data Collection Only)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Children's Healthcare of Atlanta (Data Collection and Specimen Analysis)
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Ann & Robert H. Lurie Children'S Hospital of Chicag
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
9
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
10
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
11
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York, United States, 11725
Actively Recruiting
12
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
13
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, United States, 10065
Actively Recruiting
14
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
15
Cincinnati Children's Hospital Medical Center (Data collection only)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
16
Cook Children's Health Care System (Data Collection Only)
Fort Worth, Texas, United States, 76104
Actively Recruiting
Research Team
M
Michael Ortiz, MD
J
Julia Glade Bender, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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