Status:
ACTIVE_NOT_RECRUITING
Evolutionary Therapy for Rhabdomyosarcoma
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Pediatric Cancer Foundation
Conditions:
Rhabdomyosarcoma
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 thei...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04388839
Start Date
December 29 2020
End Date
August 1 2027
Last Update
November 26 2025
Active Locations (18)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
3
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
4
University of Florida
Gainesville, Florida, United States, 32610