About this study
Rhabdomyosarcoma (RMS) is a type of cancerous tumor found in soft tissue, such as muscles. The standard treatment for newly diagnosed rhabdomyosarcoma is chemotherapy, surgery, and radiation therapy (the use of high-dose x-rays to kill cancer cells).
A patient’s prognosis can vary depending on what kind of changes (mutations) they have to the DNA of their cancer cells. Based on these mutations found in rhabdomyosarcoma patients, we have identified 3 groups of patients. These groups are based on the risk of their cancer returning after treatment:
- Low-risk
- Intermediate-risk
- High-risk
Purpose of this clinical trial
We hope to find the most effective treatment for each risk group of rhabdomyosarcoma patients. The treatment they will receive is based on the risk of their cancer returning. The risk groups include:
- Low-risk rhabdomyosarcoma: these patients will receive the standard of care treatment (vincristine, dactinomycin, and cyclophosphamide, known as “VAC”), along with surgery and radiation therapy.
- Intermediate-risk rhabdomyosarcoma: find out if adding a drug called liposomal irinotecan (also called Onivyde), along with the standard (VAC) chemotherapy/radiation/surgery, will be more effective than standard therapy alone. We also want to find the best radiation dose to give to patients who have large tumors.
- High-risk rhabdomyosarcoma: find out if alternating standard (VAC) chemotherapy with VLIT chemotherapy (vincristine/liposomal irinotecan/temozolomide), along with surgery and radiation therapy, will be more effective. We also want to find the best radiation dose to give to these patients who have large tumors.
Eligibility overview
To take part in this study, you must fit these criteria:
- Newly diagnosed with rhabdomyosarcoma (RMS)
- Low-risk, intermediate-risk, or high-risk disease, as defined in the research protocol
- Up to 21 years old
- No prior radiotherapy or chemotherapy
- No active infection