Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

NCT02509234 | Unknown

• 1 other identifier: TrI.PReSarc V150429
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

pediatric sarcomas; Ewing sarcoma; rhabdomyosarcoma; soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• Toxicity during therapy

  WHO toxicity grading

  As long as patient is undergoing therapy/ 6 months

Secondary Outcomes (3)

• Quality of life

  12 months

• Assessment of therapeutic effect

  12 months

• Assessment of time to treatment failure

  12 months

Other Outcomes (3)

• Overall survival in comparison to matched controls.

  12 months

• Differences in response rate comparing response rate in Ewing Sarcoma to response rate in Soft Tissue Sarcoma

  12 months

• Event free survival in comparison to matched controls.

  12 months

Interventions

Combined chemotherapy with trabectedin followed by irinotecan DRUG

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.

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma

You may qualify if:

• 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

You may not qualify if:

• Patients newly diagnosed or in first relapse.

Sponsors & Collaborators

• Technical University of Munich: lead

MeSH Terms

Conditions

Sarcoma, Ewing; Rhabdomyosarcoma; Sarcoma

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Myosarcoma; Neoplasms, Muscle Tissue

Study Officials

• Stefan Burdach, Prof.

  Kinderklinik München Schwabing - Klinik und Poliklinik für Kinder- und Jugendmedizin, Klinikum Schwabing, Städtisches Klinikum München GmbH und Klinikum Rechts der Isar (AöR) der Technischen Universität München

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 27, 2015
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: July 27, 2015

Record last verified: 2015-07