NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS). Primary Objectives Intermediate-Risk * To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT. * To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib

Trial Details

NCT ID
NCT06239272
Phase
PHASE1 / PHASE2
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Liposarcoma Sarcoma
Interventions
  • Surgical resection
  • Proton beam radiation therapy
  • Pazopanib
  • Ifosfamide
  • Doxorubicin
  • Selinexor
Locations (sample)
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Baton Rouge, Louisiana, United States|30.44332,-91.18747
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

  • Inclusion Criteria - All Patients
  • Patients must be ≤ 30 years at the time of the biopsy that established the diagnosis of NRSTS.
  • Surgical Resection: Patients who had an upfront resection prior to enrollment will be eligible if they are able to begin therapy within 28 days of …
  • Lansky performance status score ≥ 60 for patients ≤ 16 years of age. Karnofsky performance status score ≥ 60 for patients \>16 years of age. Note p…

For full eligibility, visit ClinicalTrials.gov.

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