EUCTR2012-002059-40-IT进行中（未招募）不适用
Potentiating clinical and immunological effects of chemotherapy by neutralizing acidic pH at tumor site: a phase II randomized study in melanoma patients - ECT-LANS-IL2
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点开始时间: 2012年9月3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
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
- •Patients with metastatic melanoma IIIC / IV M1a meeting the following inclusion criteria will be eligible for the study.
- •1. Age> 18
- •2. Melanoma skin histo-and / or cytologically confirmed.
- •3. Non- Ocular melanoma in advanced stage IIIC / IV M1 with the presence of multiple measurable cutaneous and/or subcutaneous lesions, suitable for biopsy, and for the application of electrodes;
- •4. Number of lesions equal to or greater than six with a minimum size of the lesions of 0.5 cm.
- •5. Performance status 0-2 (ECOG).
- •6. Life expectancy ? 3 months.
- •7. Locations of measurable and / or assessed metastases according to RECIST criteria confirmed by imaging. However, the evaluation of the lesions may be carried out using the clinical examination with digital photography and / or by ultrasound.
- •8. A previous chemo-and/or immune/bio-chemotherapy and/or vaccination are allowed (however, a washout period of at least 4 weeks is required).
- •9. Normal blood count (neutrophils > 1500/µL and platelet count> 130,000/mL), liver function (ALT, AST and alkaline phosphatase =2.5 x upper of normal limits [UNL], and total bilirubin <3.0 mg/ml in addition renal function (blood urea nitrogen and creatinine within the normal range, and, in particular, serum creatinine = 1.5 x UNL).
- •10. Written informed consent in accordance with the requirements of the local Ethical Committee.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1.Previous cancers diagnosed within the last 2 years, with the exception of treated basal cell carcinomas or carcinomas in situ of the cervix treated properly.
- •2.Recent major surgery (within 28 days before the start of study treatment).
- •3.Previous treatment with bleomycin at maximum dosage, and different cancer therapies administered within 4 weeks prior to ECT.
- •4.Pregnancy and lactation. Post-menopausal women should be with amenorrhea for at least 12 months.
- •5.Serious diseases of the liver or lung.
- •6.Short life expectancy (<3 months) in relation to the evolutionary picture of the disease.
- •7.Evidence of bleeding diathesis or coagulopathy.
- •8.Uncontrolled hypertension;
- •9.Congestive heart failure (NYHA grade ? 2), previous myocardial infarction or cerebrovascular events within 6 months, pulmonary hypertension, unstable angina, cardiac arrhythmia not adequately controlled by medical treatment which cause decisive alteration in severe cardiac hemodynamics requiring specific treatment;
- •10.Presence of epilepsy or history of significant neurological or psychiatric illness that would compromise the understanding and giving informed consent;
- •11.Chronic renal failure
- •12.Infection that requires intravenous antibiotic therapy and tuberculosis treatment upon entering the trial;
- •13.Active peptic ulcer, unstable diabetes mellitus and other uncontrolled significant diseases, at the investigator discretion.
- •14.A positive HIV test.
- •15.Significant alterations of complete blood count (CBC) and / or of the of hepatic/renal function indices (mentioned above).
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