Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease
Recruiting · Phase 2 · NCT06023641
Conditions: Rhabdomyosarcoma
At a glance
- Research payments reported, 2025
- $603,778
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 135
About the trial
- Sponsor
- St. Jude Children's Research Hospital
- Tested
- Vincristine (drug), Dactinomycin (drug), Cyclophosphamide (drug), Surgical Resection (procedure), Proton beam radiation or external beam radiation or brachytherapy (procedure), Liposomal irinotecan (drug), Vinorelbine (drug), Temozolomide (drug), Filgrastim, peg-filgrastim (drug)
- Dates
- Started 2024-03-13; completion 2037-10
- Results posted
- Not yet
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 cyclophosphamide. * Estimate the event-free survival for high-risk patients treated with VAC and vincristine…
From ClinicalTrials.gov, last updated 2026-06-15. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ipsen Biopharmaceuticals, Inc reported $603,778 in research payments for this study in 2025 (3 payments).
Products named: Onivyde
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Saint Jude Childrens Research Hospital $603,778
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.