Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Rhabdomyosarcoma and Other Soft Tissue Sarcomas

Exclusion Criteria

• •History of myocardial infarction, angina and cerebrovascular accident related to atherosclerosis.
• •Pulmonary disorder(e.g. FEV1 ou DLCO ≤ 70% from expected).
• •Significant hematologic or hepatic abnormality (transaminases levels \> 2.5 x ULN or serum bilirubin \> 1.5 x ULN, hemoglobin \< 8 g/dL, platelets \< 100.000/mm³, ANC \< 1.500/mm³.
• •Has other existing serious medical conditions that could adversely affect the ability of the patient to be treated in accordance with the protocol.
• •Any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives.
• •If female, is pregnant or lactating.
• •Active infection at the moment of recruitment.
• •Previous history of organ transplantation.
• •Recent surgery \< 2 months before entering study.
• •Concomitant antineoplasic therapy.
• •Patient received more than one rescue treatment, previously.
• •Previous treatment with mTor inhibitors (ex: sirolimus, temsirolimus, everolimus).
• •Use of investigational drug \< 30 days before entering study.
• •Non-controlled hyperlipidaemia: serum cholesterol (fasting) \> 300 mg/dL or 7,75 mmol/L and triglycerides (fasting) \> 2,5 x ULN.
• •Non-controlled Diabetes Mellitus defined as: glycemia (fasting) \> 1,5 x ULN.
• •Patient with hemorrhagic disorder or using oral anti-vitamin K (except Warfarin in low doses).
• •Patient with HIV infection.
• •Incapable to perform protocol visits.
• •Another neoplasia for the last 2 years (except squamous or basocellular skin cancer).
• •Hypersensitivity history to rapamycin analogs.
• •Chronic treatment with corticoids (except per oral, topical or local treatment) or another immunosuppressor agent.