Evolutionary Therapy for Rhabdomyosarcoma (NCT04388839)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (10 items).
Location: University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants with regional lymph nodes as the only site of disease are not eligible. Distant nodal sites alone are eligible
- Participants who are receiving any other investigational agents for rhabdomyosarcoma are ineligible
- Participants must not be receiving any additional medicines being given for the specific purpose of treating cancer. Alternative medications including, but not limited to cannabis based products would not be a reason for exclusion
- Participants are ineligible if they have uncontrolled intercurrent illness including, but not limited to:
- ongoing or active infection not expected to resolve with current antibiotic plan
- cardiac arrhythmia
- psychiatric illness/social situations that would limit compliance with study requirements
- Patients who are pregnant or breastfeeding are not eligible because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of starting protocol therapy.
- Participants who are considered unable to comply with the safety monitoring requirements of the study are not eligible
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (18 Sites)
- University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama
- Children's Hospital of Colorado — Aurora, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
- University of Florida — Gainesville, Florida
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida
- Moffitt Cancer Center — Tampa, Florida
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- Montefiore Medical Cancer Center — The Bronx, New York
- University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- Carolinas Medical Center, Levine Cancer Institute — Charlotte, North Carolina
- Duke Children's Hospital — Durham, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Vanderbilt - Ingram Cancer Center — Nashville, Tennessee
- University of Texas Southwestern Medical Center — Dallas, Texas
- MD Anderson — Houston, Texas
- Primary Children's Medical Center/Utah — Salt Lake City, Utah
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.