Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

This is a phase II study to determine safety and efficacy of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients. Primary Objective * Estimate event-free survival for intermediate-risk participants treated with VAC and vincristine and liposomal irinotecan (VLI) with the addition of maintenance therapy with vinorelbine and cyclophos

Trial Details

NCT ID
NCT06023641
Phase
PHASE2
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Vincristine
  • Dactinomycin
  • Cyclophosphamide
  • Surgical Resection
  • Proton beam radiation or external beam radiation or brachytherapy
  • Liposomal irinotecan
Locations (sample)
  • Palo Alto, California, United States|37.44188,-122.14302
  • Memphis, Tennessee, United States|35.14953,-90.04898
  • Fort Worth, Texas, United States|32.72541,-97.32085

Key Eligibility Criteria

  • Newly diagnosed participants with the diagnosis of rhabdomyosarcoma (RMS) of any subtype. This includes embryonal rhabdomyosarcoma (fusion negative…
  • Must have either low-, intermediate-risk or high-risk disease, defined as:
  • Low-risk: TP53 and MYOD1 negative AND
  • Embryonal, congenital/infantile spindle cell, or spindle cell/sclerosing FOXO1 fusion negative histology

For full eligibility, visit ClinicalTrials.gov.

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