FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma
Trial Parameters
Brief Summary
FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)
Eligibility Criteria
Inclusion Criteria for study entry - Mandatory at first point of study entry 1. Histologically confirmed diagnosis of RMS (except pleomorphic RMS) 2. Written informed consent from the patient and/or the parent/legal guardian Phase 1b Dose Finding - IRIVA Inclusion 1. Entered in to the FaR-RMS study at diagnosis 2. Very High Risk disease 3. Age \>12 months and ≤25 years 4. No prior treatment for RMS other than surgery 5. Medically fit to receive treatment 6. Adequate hepatic function: 1. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert's syndrome 2. ALT or AST \< 2.5 X ULN for age 7. Absolute neutrophil count ≥1.0x 109/L 8. Platelets ≥ 80 x 109/L 9. Adequate renal function: estimated or measured creatinine clearance ≥60 ml/min/1.73 m2 10. Documented negative pregnancy test for female patients of childbearing potential 11. Patient agrees to use contraception during therapy and for 12 months after last trial treatment (females) o