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NCT06023641 · ClinicalTrials.gov registry record · Phase 2
Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease
A Phase 2 study of Rhabdomyosarcoma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 3
- Study locations
NCT06023641: Recruiting Phase 2 study of Rhabdomyosarcoma, sponsored by St. Jude Children's Research Hospital.
NCT06023641 is a Phase 2 study of Rhabdomyosarcoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 135 participants, above the 65-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (108% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06023641, a Phase 2 study of Rhabdomyosarcoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 3
- Study locations
Study Summary
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, liposomal irinotecan, and temozolomide with the addition of maintenance therapy with vinorelbine and cyclophosphamide. Secondary Objectives * To assess the relation between pharmacogenetic variation in CEP72 genotype and vinca alkaloid (vincristine; vinorelbine) disposition in children with rhabdomyosarcoma. * To assess the relation between the pharmacogenetic variation in drug metabolizing enzymes and drug transporters, and the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma. * To assess the extent of inter-patient variability in the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma, and explore possible associations between drug disposition and patient specific covariates (e.g., age, sex, race, weight). * Estimate the cumulative incidence of local recurrence and overall 3-year event-free survival in patients with low-risk disease, intermediate-risk disease or high-risk disease treated with either no adjuvant radiation or minimal volume radiation and compare these outcomes with the outcomes achieved on RMS13.
Primary Outcome
MTD is defined in the study as the highest treatment dose that would deliver desirable treatment effects without resulting in a target toxicity rate greater than 0.3. For each of three groups (intermediate-risk, high-risk, and intermediate-and-high-risk-with-early-radiation), we will employ the Bayesian optimal interval (BOIN) design to find the MTD.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Surgical Resection
- DRUG Vincristine
- DRUG Dactinomycin
- PROCEDURE Proton beam radiation or external beam radiation or brachytherapy
Study Locations (3)
California
- Stanford University - Palo Alto
Tennessee
- St. Jude Children's Research Hospital - Memphis
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2037-10 |
| Phase | Phase 2 |
What NCT06023641 shows while recruiting
NCT06023641 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 65-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (108% higher).
The record links to 1 condition, with Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06023641 reports a single indexed study location in California, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT06023641 about?
NCT06023641 is a clinical study titled "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 gi...
What is the current status of trial NCT06023641?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2024-03-13. Estimated completion is 2037-10.
What conditions does trial NCT06023641 study?
This clinical trial studies the following conditions: Rhabdomyosarcoma.
What interventions are being tested in trial NCT06023641?
The interventions under investigation include: Cyclophosphamide (DRUG), Surgical Resection (PROCEDURE), Vincristine (DRUG), Dactinomycin (DRUG), Proton beam radiation or external beam radiation or brachytherapy (PROCEDURE).
Who is sponsoring clinical trial NCT06023641?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06023641 being conducted?
This trial has 3 study locations across California, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rhabdomyosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06023641's enrollment target sits among peer trials
135 4th of 35 higher than 32 of 35 other Rhabdomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rhabdomyosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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