TCELLLYMPHOMA C84
Conditions
Interventions
Group 1: 150-300mg / m bexarotene daily per os for at least 24 weeks
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of bexarotene monotherapy in various defined CTCL subtypes | — |
Countries
Germany, Switzerland
Contacts
Public ContactMichael Weichenthal
Klinik für Dermatologie, Venerologie und Allergologie Christian-Albrechts-Universität zu Kiel
Outcome results
None listed