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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity during therapy | WHO toxicity grading | As long as patient is undergoing therapy/ 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assessment of therapeutic effect |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in comparison to matched controls. | 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 |
Inclusion Criteria:
Key Exclusion Criteria:
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Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST.
| 12 months |
| Assessment of time to treatment failure | Read out after every two cycles (functional imaging, PET-MRT/PET-CT), evaluation according to RECIST. | 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. | Comparison of event free survival in a matched pair analysis. | 12 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |