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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06023641
The ClinicalTrials.gov registry entry for NCT06023641 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 65-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (108% higher). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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