Study on Different Chemotherapy Strategies for Rhabdomyosarcoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials ID:NCT04388839
This clinical trial is exploring four different chemotherapy approaches for treating newly diagnosed patients with metastatic Fusion Positive Rhabdomyosarcoma. Patients and their doctors can choose from four treatment options, including a first strike therapy, a maintenance therapy, an adaptively timed therapy, or conventional chemotherapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to test four different chemotherapy strategies for patients who have just been diagnosed with metastatic Fusion Positive Rhabdomyosarcoma, a type of cancer. Patients and their doctors can choose from four treatment plans: a first strike therapy, a first strike followed by maintenance therapy, an adaptively timed therapy, or the standard chemotherapy treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a new diagnosis of rhabdomyosarcoma confirmed by specific tests.
- Must have enough tissue samples available for additional testing.
- Must have cancer that has spread to distant parts of the body, confirmed by biopsy or scans.
- No previous chemotherapy treatment.
- Must be able to take oral cyclophosphamide if choosing the maintenance therapy option.
- Must agree to use at least two methods of birth control or abstain from sex during and after treatment.
- Women must use birth control for 4 months after treatment ends.
- Men must use birth control for 4 months after treatment ends if sexually active with women who can become pregnant.
- Must be able to understand and sign a consent form, with help from parents or guardians if needed.
Exclusion Criteria
- Cannot participate if cancer is only in regional lymph nodes.
- Cannot be taking other experimental treatments for rhabdomyosarcoma.
- Cannot be taking other cancer-specific medications, but alternative treatments like cannabis are allowed.
- Cannot have uncontrolled health issues like ongoing infections, heart problems, or mental health issues that affect study participation.
- Cannot be pregnant or breastfeeding; women must have a negative pregnancy test before starting treatment.
- Cannot participate if unable to follow the study's safety monitoring requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | 35294 | Birmingham | Alabama |
| Children's Hospital of Colorado | 80045 | Aurora | Colorado |
| Connecticut Children's Medical Center | 06106 | Hartford | Connecticut |
| University of Florida | 32610 | Gainesville | Florida |
| University of Miami - Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Johns Hopkins All Children's Hospital | 33701 | Saint Petersburg | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Montefiore Medical Cancer Center | 10467 | Bronx | New York |
| Roswell Park Comprehensive Cancer Center | 14263 | Buffalo | New York |
| University of North Carolina Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
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