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Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

NCT02509234 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2015-07-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • 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

Eligibility

Min Age
10 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-07-31
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02509234 on ClinicalTrials.gov