EUCTR2004-001746-32-DE进行中（未招募）不适用
Phase II clinical trial with Caelyx mono-chemotherapy in patients with advanced Mycosis fungoides stage IIb, IVa and IVb with or without previous chemotherapy - /
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 48 人开始时间: 2005年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •- Histopathologically confirmed diagnosis of Mycosis fungoides * stage IIb, IVa, or Ivb
- •- No CNS involvement and no Erythroderma (T4),
- •- Refractory or recurrent disease after at least two or more previous therapies(steroids local and/or systemic, retinoids, PUVA, IFN-a, local BCNU, systemic chemotherapy, etc),
- •- Patients requiring systemic treatment with steroids, for any reason, at the moment of study entry are excluded.
- •- Prior systemic chemotherapy is allowed if all the following conditions are met:
- •1. Antracycline cumulative dose <200mg/m2,
- •2. No allergy to anthracyclines
- •3. Low dose MTX (weekly dose<30 mg)
- •- No administration of chemo-, immuno- or radiotherapy within the previous 2 weeks before trial entry. Patients must have completely recovered from all acute toxicities (excluding alopecia).
- •- Age >18 years,
- •- Karnofsky performance index = 60
- •- No other prior or concurrent primary malignant tumor (except adequately treated in situ carcinoma of the cervix uteri or squamos or basal cell skin carcinoma).
- •- No active infection requiring specific therapy (antibiotics, anti HIV therapy),
- •- Left ventricular ejection fraction within normal limits (WNL) for each institution measured by echocardiography or by radionuclide angiocardiography,
- •- Adequate hematologic function (hemoglobin > 10g/dl, WBC >2x109/l, platelets > 75000/mm3, neutrophiles >1.5x109/l),
- •- Adequate renal and liver functions (serum creatinine and serum bilirubin = 1.5 x the upper limit of normal for the institution and SGOT, SGPT = 2.5 x the upper limit of normal for the institution),
- •- Female patients potentially childbearing and without effective contraception, pregnant or lactating are excluded. Women of childbearing potential must have a negative pregnancy test within one week before entry into the trial.
- •- Male patients who agree to practice an effective method of contraception during the entire period of treatment,
- •- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial,
- •- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •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
- 未提供
研究者
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