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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05985161
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    This phase II study will initially treat all patients, including adult patients, at the pediatric Selinexor RP2D of 35 mg/m2 (maximum dose 100mg/dose) once weekly using a liquid suspension .

Study Details

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, BCOR-driven sarcoma, or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes that increase the activity of XP01.

Key Dates

Start date
Aug 1, 2023
Status verified
May 2026
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A.1 Wilms Tumor
    Participants will have any type of Wilms tumor or nephroblastoma
  • Experimental: Cohort B.1 Rhabdoid Tumor
    Participants will have any Rhabdoid tumor
  • Experimental: Cohort C.1 MPNST
    Participants will have progressive, relapsed, unresectable or metastatic MPNST
  • Experimental: Cohort D.1 Other Solid Tumor
    Participants must not qualify for Cohorts A, B, or C but have a solid tumor (no hematologic malignancies including lymphoma) for which there is specific evidence that this particular patient's tumor may benefit from selinexor.
  • Experimental: Cohort E.1g BCOR driven sarcoma
    Patients must have a solid tumor with an activating genomic alteration (e.g. fusion or internal tandem duplication) involving BCOR. Specific examples of qualifying alterations including BCOR-ITD, BCOR-CCNB3,BCOR-MAML3 and ZC3H7B-BCOR;Other potentially qualifying BCOR alterations require approval of study principal investigator; note that loss of function alterations of BCOR would not qualify.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 6 months following the start of the treatment ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los Angeles (Data Collection Only)Los AngelesCalifornia90027
Rachana Shah, MD
323-660-2450
Stanford Medicine Children's Health (Data Collection Only)Palo AltoCalifornia94304
Chelsey Burke, MD
650-497-8953
Children's National Hospital (Data Collection Only)Washington D.C.District of Columbia20010
Aerang Kim, MD
888-884-2327
Children's Healthcare of Atlanta (Data Collection and Specimen Analysis)AtlantaGeorgia30322
Thomas Cash, MD
404-785-0910
Ann & Robert H. Lurie Children'S Hospital of ChicagChicagoIllinois60611
Elizabeth Sokol, MD
800-543-7362
Dana Farber Cancer Institute (Data Collection Only)BostonMassachusetts02115
Elizabeth Mullen, MD
617-632-1938
Washington UniversitySt LouisMissouri63110
Amy Armstrong, MD
314-454-6018
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Michael Ortiz, MD
833-675-5437
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Michael Ortiz, MD
833-675-5437
Memorial Sloan Kettering Bergen (Limited protocol activities)MontvaleNew Jersey07645
Michael Ortiz, MD
833-675-5437
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )CommackNew York11725
Michael Ortiz, MD
833-675-5437
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Michael Ortiz, MD
833-675-5437
Memorial Sloan Kettering Cancer Center (All protocol activites)New YorkNew York10065
Michael Ortiz, MD
833-675-5437
Memorial Sloan Kettering Nassau (Limited protocol activities)Rockville CentreNew York11553
Michael Ortiz, MD
833-675-5437
Cincinnati Children's Hospital Medical Center (Data collection only)CincinnatiOhio45229
Brian Turpin, DO
513-636-3200
Cook Children's Health Care System (Data Collection Only)Fort WorthTexas76104
Kelly Vallance, MD, MPH
682-885-4007

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles (Data Collection Only)· Los Angeles, CAStanford Medicine Children's Health (Data Collection Only)· Palo Alto, CAChildren's National Hospital (Data Collection Only)· Washington D.C., DCChildren's Healthcare of Atlanta (Data Collection and Specimen Analysis)· Atlanta, GAAnn & Robert H. Lurie Children'S Hospital of Chicag· Chicago, ILDana Farber Cancer Institute (Data Collection Only)· Boston, MA

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