Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

Recurrent Childhood Soft Tissue Sarcoma Clinical Trial

— TrIPReSarc  

Official title:

Trabectedin and Irinotecan in Pediatric Refractory Sarcomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02509234
• Other study ID #: TrI.PReSarc V150429
• Status: Active, not recruiting
• Phase: N/A
• First received: July 1, 2015
• Last updated: July 24, 2015
• Start date: February 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 40 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Recurrent Childhood Soft Tissue Sarcoma
• Recurrent Ewing Sarcoma
• Recurrent Rhabdomyosarcoma
• Rhabdomyosarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• Combined chemotherapy with trabectedin followed by irinotecan
Day 1: Trabectedin 1,1 - 1,5 mg/m²/day i.v. Day 3-5 and 10-12: Irinotecan 30- 90 mg/m²/day p.o. or i.v.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival in comparison to matched controls.	Comparison of overall survival in a matched pair analysis.	12 months	No
Other	Differences in response rate comparing response rate in Ewing Sarcoma to response rate in Soft Tissue Sarcoma	Statistical comparison of response rate according to RECIST in Ewing Sarcoma vs. Soft Tissue Sarcoma	12 months	No
Other	Event free survival in comparison to matched controls.	Comparison of event free survival in a matched pair analysis.	12 months	No
Primary	Toxicity during therapy	WHO toxicity grading	As long as patient is undergoing therapy/ 6 months	No
Secondary	Quality of life	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.	12 months	No
Secondary	Assessment of therapeutic effect	Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.	12 months	No
Secondary	Assessment of time to treatment failure	Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.	12 months	No