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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
IV push over 1 minute with dosing ranging from 0.24mg up to 1.5mg
IV over 60 minutes with dosing ranging from 220mg to 1200mg
IV push over 6-10 minutes with dosing ranging from 4mg-25mg
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Children's Hospital of Colorado
First Strike Event Free Survival
Participants who choose the first strike treatment will have event free survival assessed at 3 years after initiating treatment. Event free survival is defined as time from treatment initiation to event which includes (1) any recurrence (local or regional, or distant) and (2) death due to any cause.
Time frame: Baseline to 3 years
Second Strike Event Free Survival
Participants who choose the second strike treatment will have event free survival assessed at 3 years after initiating treatment. Event free survival is defined as time from treatment initiation to event which includes (1) any recurrence (local or regional, or distant) and (2) death due to any cause
Time frame: Baseline to 3 years
Adaptive Therapy Event Free Survival
Participants who choose the adaptive therapy will have event free survival assessed at 3 years after initiating treatment. Event free survival is defined as time from treatment initiation to event which includes (1) progression that does not respond to additional VAC dosing and (2) death due to any cause
Time frame: Baseline to 3 years
Overall Survival
The time to event endpoint of overall survival is defined as the duration of time from diagnosis to death or last follow-up, where event would be death from any cause
Time frame: 5 years
Treatment-related adverse events of a certain grade or higher
Number of participants with treatment-related adverse events of a certain grade or higher and hematological/biochemical toxicities based on laboratory measurements as assessed by CTCAE v5.0
Time frame: Baseline to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Based on Body Surface Area (BSA) round to nearest 25mg
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
...and 8 more locations