EUCTR2023-000169-14-IT招募中1 期
Phase II Prospective Multicenter Study of High-Dose Treosulfan/Melphalan as Consolidation Treatment in Newly Diagnosed High-Risk and Very High-Risk Ewing Sarcoma
Fondazione Santobono Pausilipon ONLUS0 个研究点目标入组 60 人开始时间: 2023年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Diagnosis: Newly diagnosed and histologically confirmed, localized or metastatic Ewing sarcoma or Ewing-like sarcoma of bone or soft tissue. Patients with disseminated ES are included if any of the following conditions are present: a) 0-5 bone lesions at age < 14 years; b) 0-1 bone lesion at age > 14 years; c) BM involvement; d) Extraosseous metastases + BM involvement or + bone lesion(s) with the aforementioned age-cut-offs.
- •2.Informed Consent: According to regional laws, national and GCP guidelines, before any study-specific activity, including screening evaluation, provision of written and signed informed consent from each patient or the patient’s legally acceptable representative, parent(s) or legal guardian, is required. Willingness and ability to comply with scheduled visits and study procedures as required.
- •3.Age < 50 years old at the date of diagnostic biopsy. Patients aged < 18 years must be treated in centers accredited to treat pediatric ES patients.
- •4.Registration: = 45 days from diagnostic biopsy/surgery.
- •5.Performance Status: Karnofsky Performance Status > 50% for participants > 16 years old or Lansky Play Score > 50% for pediatric participants = 16 years old, or ECOG = 2 for adult participants. These levels may be modified for handicapped patients or patients for whom a lower score is linked to tumor burden.
- •6.Adequate bone marrow function, defined as:
- •Peripheral absolute neutrophil count (ANC) > 2 ×10 9 /L
- •Hemoglobin > 8.0 g/dL (transfusion allowed)
- •Platelet count > 80 × 10 9 /L (transfusion allowed).
- •7.Adequate organ function, defined as:
- •Serum creatinine < 1.5 x upper limit of normal (ULN)
- •Calculated creatinine clearance (CL) >60 mL/min as determined by Cockcroft-Gault (using actual body weight):
- •-Males: Creatinine CL = Weight (kg) × (140 - Age) (mL/min) 72 × serum creatinine (mg/dL);
- •-Females: Creatinine CL = Weight (kg) × (140 - Age) × 0.85 (mL/min) 72 × serum creatinine (mg/dL)
- •Serum bilirubin = 1.5 × ULN, except for Gilbert´s Syndrome
- •Serum lipase and amylase = 1.5 × ULN
- •Alanine transaminase and AST = 2.5 × ULN; for patients with hepatic metastases, ALT and AST = 5.0 × ULN
- •Normal ventricular ejection fraction: LVEF > 40% SF > 28%.
- •8.Contraception: female participants of childbearing potential must have a negative pregnancy test before enrolment and once a month during therapy. By signing the informed consent, female and male participants who are sexually active must agree to use an effective form of contraception with their sexual partners through to 6 months beyond the end of treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.The presence of > 5 bone lesions at age < 14 years or > 1 bone lesion at age > 14 years. Bone lesions must be confirmed by CT scan, MRI, PET scan or, in doubtful cases, by biopsy.
- •2.Presence of concomitant bone metastases plus bone marrow involvement (at least one site positive for metastatic infiltration).
- •3.Previous or concurrent chemotherapy or radiotherapy treatment.
- •4.Cardiac: clinically significant, uncontrolled, or active cardiac disease, including:
- •a)Myocardial infarction within 6 months before enrolment.
- •b)Unstable angina within 6 months before enrolment.
- •c)Congestive heart failure within 6 months before enrollment, or left ventricular ejection fraction (LVEF) less than the lower limit of normal per local institutional standards.
- •d)History of clinically significant atrial arrhythmia.
- •e)Any history of ventricular arrhythmia.
- •5. Vascular: Clinically significant, uncontrolled, or active vascular disease, or other arterial or venous vascular occlusion diseases including:
- •a)Uncontrolled hypertension, according to age values. Patients with hypertension should be under treatment on study entry to carry out blood pressure control.
- •b)Cerebrovascular accident or transient ischemic attack within 6 months before enrolment
- •c)Any history of peripheral arterial occlusive disease requiring revascularization
- •d)Venous thromboembolism including deep venous thrombosis or pulmonary embolism within 6 months before enrolment.
- •6. Uncontrolled Hypertriglyceridemia: Triglycerides > 450 mg/dl.
- •7. Ongoing or Active Infection.
- •8. History of Bleeding Disorder.
- •9. History of Acute Pancreatitis: within 1 year before study treatment or history of chronic pancreatitis.
- •10. History of Alcohol Abuse.
- •11. Secondary Malignancy.
- •12. Pregnancy or Lactation.
- •13. Any other medical, psychiatric, or social condition incompatible with protocol treatment.
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