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Evolutionary Therapy for Rhabdomyosarcoma

NCT04388839 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Pediatric Cancer Foundation

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jonathan Metts, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388839 on ClinicalTrials.gov