Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

Trabectedin and Irinotecan in Pediatric Refractory Sarcomas

The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.

Inclusion Criteria:

• Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention)
• existing matched control in existing study databases
• have started of treatment within three months of last progress

Key Exclusion Criteria:

• Patients newly diagnosed or in first relapse.