EUCTR2009-012644-16-IT进行中（未招募）不适用
PHASE 2 SINGLE- ARM STUDIES OF TEMOZOLOMIDE IN COMBINATION WITH TOPOTECANIN REFRACTORY AND RELAPSED NEUROBLASTOMA AND OTHER PAEDIATRIC SOLID TUMOURS - TOTEM 2
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点目标入组 93 人开始时间: 2009年5月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically or cytologically confirmed neuroblastoma, brain tumours, or other solid tumours (at diagnosis, no additional biopsy needs to be performed for the purpose of the study)
- •- Relapsed or refractory tumours in which correct standard treatment approaches have failed
- •- No more than 2 lines of prior chemotherapy
- •- Measurable primary and/or metastatic disease on CT/MRI: at least one bi-dimensionally measurable lesion
- •For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring
- •- Age at inclusion: 6 months to ≤ 20 years
- •- Lansky play score ≥ 70% or ECOG performance status ≤ 1
- •- Life expectancy ≥ 3 months
- •- Adequate organ function:Adequate haematological function: haemoglobin ≥ 80 g/L, neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L; in case of bone marrow disease: neutrophils ≥ 0.5 x 109/L and platelets ≥ 75 x 109/L;
- •Adequate renal function: normal creatinine related to patient?s age: 0 ? 1 year: ≤ 40 μmol/L 1 ? 15 years: ≤ 65 μmol/L 15 ? 20 years: ≤ 110 μmol/L
- •Adequate hepatic function: bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (AST, ALT ≤ 5 x ULN in case of liver metastases)
- •- Wash out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study
- •- Patients previously treated with only one of the 2 drugs are eligible
- •- Able to comply with scheduled follow-up and with management of toxicity
- •- All patients with reproductive potential must practice an effective method of birth control while on study. Female patients aged > 12 years must have a negative pregnancy test within 7 days before study treatment
- •- Written informed consent from patient, parents or legal guardian.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Concurrent administration of any other anti-tumour therapy
- •- Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient?s ability to complete the study
- •- History of allergic reaction to the compounds or their solvents
- •- History of allergic reaction to Dacarbazine (DITC)
- •- Galactosemia, Glucose-galactose malabsorption or lactase deficiency
- •- Pregnant or breast feeding young women
- •- Presence of symptomatic brain metastases in patients with solid non-CNS tumours.
研究者
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