Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

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

• Registration Number: NCT02509234
• Lead Sponsor: Technical University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Status Verified: 2015-07
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-24
• Last Update Submitted: 2015-07-24
• Study First Posted: 2015-07-27
• Last Update Posted: 2015-07-27
• Primary Completion: 2016-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity during therapy	As long as patient is undergoing therapy/ 6 months	WHO toxicity grading

Secondary Outcome Measures

Name	Time	Method
Quality of life	12 months	Assessment of quality of life at the day before starting the next cycle and at months 3, 6, 9 and 12 after start of treatment, using adapted Karnofsky Score.
Assessment of therapeutic effect	12 months	Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
Assessment of time to treatment failure	12 months	Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.