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Trabectedin and Irinotecan fo...

Trabectedin and Irinotecan for Refractory Pediatric Sarcomas

Last Updated: 2015-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma Recurrent Rhabdomyosarcoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* Patients newly diagnosed or in first relapse.

Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Burdach, Prof.

Role: STUDY_CHAIR

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