EUCTR2006-003978-10-IT进行中（未招募）不适用
Pilot Study with fixed dose of Cisplatinum in combination with esomeprazole (dose-ranging) as salvage treatment in patients with pre-treated advanced/methastatic melanoma - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1. age >18 and <75 years 2. Histo- and/or cytologically confirmed skin melanoma 3. Advanced non-ocular melanoma, non-operable (stage IIIC, non-treatable with hypotermic-antiblastic perfusion or recurrent after such, stage IV), in presence of multiple biopsable subcutaneous or lymphonodal lesions 4. Performance status 0-1 (ECOG) 5. Life expectancy more or equal to 3 months 6. Measurable and/or evaluable sites of metastasis, confirmed by imaging (simple X-rays, echography of soft tissue, CAT and NMR ? diameter at least 1 cm) 7. A previous chemioterapic treatment containing decarbazine or fotemustine and/or immuno/biochemiotherapy with IFN/IL-2 and/or a vaccine are allowed (anyhow, a wash period of at least 4 weeks is requested) 8. Normal haemochromocytometric exam: neutrophiles >1500/microlitres and platelet count >30.000 microlitres, liver functionality (ALT, AST levels and Alkaline phosphatase less or equal to 2.5x upper normal limits, creatinemia within normal range, and particulary cratinin clearance >50 mL/min or creatinemia lesso or equal to 1.5x UNL) 9. Informed Consent written according to Local ethical Committee requests 10. Patient accessibility to treatment and follow-up 11. Complete work-up within 4 weeks before treatment start
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous tumors, diagnosed in last 5 years, with the exception of treated skin carcinomas or in situ, properly treated cervix carcinomas. 2. Pregnancy and breast-feeding. Women in post-menopause must present amenorrea since 12 months at least. Sexually active males and females (in fertile age) who do not want to use contraception during the trial. 3. Recent major surgery interventions (within 28 days before study treatment) 4. Planned radiotherapy for melanoma metastasis 5. Clinical or radiological evidence of metastasis in Central Nervous System (CNS) 6. Positive clinical history for other important pathologies: a. evidence of haemorrhagic diathesis or coagulopathy; b. non-controlled hypertension c. congestitial cardiac insufficiency (NYHA stage more or equal to 2), previous myocardial infarction or cerebrovascular events within 6 months, unstable angina, severe heart arythmia requiring specific treatment; d. History of significant neurological or psychiatric pathologies which would compromise the comprehension and the issuing of the informed consent; e. infection requiring an antibiotic therapy by EV and tuberculosis in treatment at the moment of trial start; f. active peptic ulcer, unstable diabetes mellitus, cyrrosis and other significant pathologies
研究者
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