Trabectedin and Irinotecan for Refractory Pediatric Sarcomas (TrIPReSarc)

July 24, 2015 updated by: Technical University of Munich

Trabectedin and Irinotecan in Pediatric Refractory Sarcomas

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity during therapy
Time Frame: As long as patient is undergoing therapy/ 6 months
WHO toxicity grading
As long as patient is undergoing therapy/ 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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.
12 months
Assessment of therapeutic effect
Time Frame: 12 months
Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
12 months
Assessment of time to treatment failure
Time Frame: 12 months
Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival in comparison to matched controls.
Time Frame: 12 months
Comparison of overall survival in a matched pair analysis.
12 months
Differences in response rate comparing response rate in Ewing Sarcoma to response rate in Soft Tissue Sarcoma
Time Frame: 12 months
Statistical comparison of response rate according to RECIST in Ewing Sarcoma vs. Soft Tissue Sarcoma
12 months
Event free survival in comparison to matched controls.
Time Frame: 12 months
Comparison of event free survival in a matched pair analysis.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (Estimate)

July 27, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 24, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TrI.PReSarc V150429

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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