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The purpose of this study is to determine the Everolimus aim response in children and adolescents with refractory or relapsed Rhabdomyosarcoma and other soft tissue sarcomas
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus will be administered every day, initial dose 5 mg/m²/day, in 28 days cycle. Maximum dose: 10 mg/day. The cycles will be repeated till progression disease or untolerable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Everolimus aim response in children and adolescents with refractory and relapsed Rhabdomyosarcoma and other soft tissue sarcomas | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Define Everolimus toxicity in this population | Up to 2 years |
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Inclusion Criteria:
Age Maximum serum creatinine (mg/dL) 0 - 29 days 0,4 - 0,7 1 month - 3 years 0,7 4 - 7 years 0,8 8 - 10 years 0,9 11 - 12 years 1,0 13 - 17 years 1,2
≥ 18 years 1,3
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sidnei Epelman, MD | Contact | +55 11 2522-2472 | pesquisaoncoped@santamarcelina.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa de Saúde Santa Marcelina | Recruiting | São Paulo | São Paulo | 08270070 | Brazil |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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