A Multi-Center Phase II Study of Selinexor in Treating Recurrent or Refractory Wilms Tumor and Other Pediatric Solid Tumors
Memorial Sloan Kettering Cancer Center
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, 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.
Eligibility
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age: 1. Age ≥ 6 at the time of informed consent 2. Age ≥ 2 years to \< 6 years at time of informed consent (Refer to Section 4.3): If PK cohort 1 is open, patients in this age range may enroll onto this cohort. If PK cohort 1 has been completed and deemed sufficient to proceed, then such patients may enroll onto the phase 2. 3. Age ≥ 12 months to \< 2 years at time of informed consent (Refer to Section 4.3): If PK cohort 2 is open, patients in this age range may enroll onto this cohort. If PK cohort 2 has been completed and deemed sufficient to proceed, then such…
Interventions
- DrugSelinexor
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 .
Locations (16)
- Children's Hospital of Los Angeles (Data Collection Only)Los Angeles, California
- Stanford Medicine Children's Health (Data Collection Only)Palo Alto, California
- Children's National Hospital (Data Collection Only)Washington D.C., District of Columbia
- Children's Healthcare of Atlanta (Data Collection and Specimen Analysis)Atlanta, Georgia
- Ann & Robert H. Lurie Children'S Hospital of ChicagChicago, Illinois
- Dana Farber Cancer Institute (Data Collection Only)Boston, Massachusetts