NCT04388839

Evolutionary Therapy for Rhabdomyosarcoma

Evolutionary Inspired Therapy for Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Rhabdomyosarcoma

Interventions

Type	Name	Description
DRUG	Vincristine	IV push over 1 minute with dosing ranging from 0.24mg up to 1.5mg
DRUG	Cyclophosphamide	IV over 60 minutes with dosing ranging from 220mg to 1200mg
DRUG	Vinorelbine	IV push over 6-10 minutes with dosing ranging from 4mg-25mg
DRUG	Actinomycin D	Actinomycin D should not be given with radiation. Will be administered through IV over 3-5 minutes with dosing ranging from 0.025mg-0.045mg
DRUG	Cyclophosphamide Pill	Based on Body Surface Area (BSA) round to nearest 25mg

Timeline

• Start date: 2020-12-29
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2020-05-14
• Last updated: 2025-11-26

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study