DRKS00003693招募中4 期
ADO CTCL-3 (Tarado): Multicentric therapy protocol for bexarotene (Targretin ®) monotherapy in pretreated CTCL stage =Ib with clear assignment to a EORTC-Diagnosis - Tarado
niversitätsklinikum Schleswig-Holstein Campus Kiel0 个研究点目标入组 200 人开始时间: 2012年12月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Histopathologically documented CTCL stage = Ib and grading by EORTC (Appendix K)
- •Staging, EORTC classification
- •2. Pretreatment with PUVA if a continuation of the PUVA is no longer possible or with inadequate response
- •3. Karnofsky performance status> 60%
- •4. Age = 18 years
- •5. Adequate organ function (blood count, liver, kidney, cardiac function, electrolytes, lipids)
- •6. Neg. Pregnancy test, efficient contraception in male and female patients (bexarotene could lead to decreased efficacy of hormonal contraceptives)
- •7. No other active malignancy
- •8. No topical chemotherapy, photopheresis or interferon treatment to 28 days prior to study entry
- •9. No topical treatment (steroids, tar-bath), superficial radiotherapy, treatment with other retinoids or beta-carotene two weeks ago baseline *
- •10. No serious systemic disease or infection at study entry
- •11. No participation in another study in the last 14 days prior to study entry
- •12. No pre-treatment with Targretin
- •13. Lack of psychological, familial, sociological or geographical obstacles that hinder the study protocol or the follow-up control
- •14. No contraindications to treatment with bexarotene (known hypersensitivity to retinoids, hypervitaminosis A, status after pancreatitis, alcohol abuse, drugs that can be toxic to the pancreas or increase lipid levels, uncontrolled diabetes mellitus, uncontrolled (thyroid disorder)
- •15. A signed consent of the patient
- •*Continuous topical steroid applications before and during treatment withTargretin
排除标准
- •1. Mucosal or ocular melanoma melanoma
- •2. Intransitmetastasen
- •3. Other adjuvant therapy (systemic therapy with an immunomodulator of a previous operation is allowed, provided that the last dose at least 30 days earlier; prior radiotherapy before lymphadenectomy is allowed)
- •4. Autoimmune disorders (vitiligo außgenommen)
- •5. Immunodeficiency
- •6. Other malignancies (excluding carcinoma in situ of the cervix or remission over 5 years)
- •7. Uncontrolled bleeding
研究者
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