Trabectedin and Irinotecan for Refractory Pediatric Sarcomas (TrIPReSarc)

Technical University of Munich

Status: Unknown

Conditions: Recurrent Ewing Sarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Rhabdomyosarcoma

Treatments: Drug: Combined chemotherapy with trabectedin followed by irinotecan

Study type: Observational

Funder types: Other

Identifiers

NCT02509234

TrI.PReSarc V150429

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.