Evolutionary Therapy for Rhabdomyosarcoma
Running, not enrolling · Phase 2
Conditions studied: Rhabdomyosarcoma
In brief
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.
Key facts
- Study ID
- NCT04388839
- Run by
- H. Lee Moffitt Cancer Center and Research Institute
- People needed
- 12
- Starts
- 2020-12-29
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2025-11-26
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must have a new histologic diagnosis of rhabdomyosarcoma
- Participants must have FISH, PCR or other molecular confirmation of PAX/FOXO1 fusion per institutional standards
- Participants must have sufficient tissue (up to 10 unstained FFPE) for correlative testing
- All participants must have distant metastatic disease; either biopsy positive or PET avid extranodal or distant nodal lesions determined by the investigator to be metastatic disease. Patients with a single distant metastatic site that has been excised prior to study entry are eligible
- No prior systemic chemotherapy
- Participants enrolled to Arm B, maintenance, must be able to take oral cyclophosphamide. Note: enteral administration of cyclophosphamide is allowable.
- Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence.
- Women of childbearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration
- Men who are sexually active with women of child bearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration
- All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
- Children's Hospital of Colorado — Aurora, Colorado, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- University of Florida — Gainesville, Florida, United States
- University of Miami - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
- Montefiore Medical Cancer Center — The Bronx, New York, United States
- University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Carolinas Medical Center, Levine Cancer Institute — Charlotte, North Carolina, United States
- Duke Children's Hospital — Durham, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- MD Anderson — Houston, Texas, United States
- Primary Children's Medical Center/Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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