Study on Selinexor for Treating Wilms Tumors and Other Solid Tumors

Inclusion Criteria

• Age:
  • 6 years or older at the time of consent.
  • 2 to under 6 years if certain study conditions are met.
  • 12 months to under 2 years if certain study conditions are met.
• Consent: Must sign a consent form; assent will be obtained when appropriate.
• Performance: Must have a performance score of 60% or higher.
• Diagnosis: Must fit into one of the following groups:
  • Cohort A: Wilms tumor with specific conditions like multiple relapses or certain treatment histories.
  • Cohort B: Rhabdoid tumors, including specific subtypes, after failing at least one treatment.
  • Cohort C: MPNST that is progressive, relapsed, or cannot be removed, after failing at least one treatment.
  • Cohort D: Other solid tumors with evidence that selinexor may help, after failing at least one treatment.
• Disease Status: Must have measurable disease for phase II or evaluable/measurable disease for certain study parts.
• Prior Therapy: Must have recovered from previous treatments and meet specific timeframes since last treatment.
• Hepatic Function: Must have adequate liver function based on specific tests.
• Renal Function: Must have adequate kidney function based on specific tests.
• Hematologic Function: Must have adequate blood cell counts without recent transfusions or growth factor support.

Exclusion Criteria

• Prior Therapy: Cannot have previously received selinexor or similar drugs.
• Infection: Cannot have an uncontrolled infection.
• Transplants: Cannot have had a solid organ transplant; bone marrow transplant patients may be eligible under certain conditions.
• Compliance: Must be able to comply with study requirements.
• Pregnancy and Breast-feeding: Cannot be pregnant or breastfeeding; pregnancy tests required for post-menarchal girls.
• Contraception: Must agree to use two effective birth control methods if of reproductive potential.