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First received: August 27, 2023

Clinical Trial: Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Rhabdomyosarcoma

Study Type: INTERVENTIONAL


Official Title: A Protocol for the Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

Brief Summary: This is a phase I-II study to determine safety and efficacy of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients.Primary ObjectiveThe primary objective of the Phase I part is to estimate the maximum tolerated doses (MTDs) and recommended Phase II doses…

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