drugset
drugset / Trial / NCT04388839

Evolutionary Therapy for Rhabdomyosarcoma

NCT04388839 ↗

Phase 2 Active not recruiting 12 enrolled H. Lee Moffitt Cancer Center and Research Institute National Pediatric Cancer Foundation · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.

Timeline

Start
2020-12-29
Primary completion
2026-08
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 220 mg Intravenous
Subject Cyclophosphamide Other / unclassified 1200 mg Intravenous
Subject Dactinomycin Protein / enzyme biologic 0.025 mg Intravenous
Subject Dactinomycin Protein / enzyme biologic 0.045 mg Intravenous
Subject Vincristine Small molecule 0.24 mg Intravenous
Subject Vincristine Small molecule 1.5 mg Intravenous
Subject Vinorelbine Small molecule 4 mg Intravenous
Subject Vinorelbine Small molecule 25 mg Intravenous

Indications

rhabdomyosarcoma