Combined Local Immunotherapy and Radiotherapy in metastatic Melanoma: an interventional single-arm trial

St George's Healthcare NHS Trust (UK)0 个研究点目标入组 30 人开始时间: 2009年11月19日最近更新: 2018年1月8日

适应症

试验速览

暂无简介。

•1. Both males and females, aged 16 to 85 years
•2. Patients who have one or more malignant skin tumours confirmed histologically at diagnosis
•3. Patients with malignant skin tumours for whom other standard therapy options are no longer appropriate or have been refused by the patient
•4. Life expectancy of at least 3-6 months
•5. Patients with a WHO performance status of 0, 1 or 2
•6. Patients who are informed of and are willing and able to comply with the home application of the Aldara® cream
•7. Patients who are willing and able to comply with the investigational nature of the study and who have signed a written informed consent form
•8. Patients who are willing to receive the number of intra-lesional injections and biopsies required to complete the study

•1. Patients with unstable or severe current medical conditions or active, uncontrolled infection
•2. Patients with psychological or sociological conditions, addictive disorders or family problems which would preclude compliance with the protocol
•3. Patients undergoing therapy at study entry with other investigational agents that are directly immunosuppressive
•4. Patients having procreative potential who are not using adequate contraception
•5. Patients with untreated/uncontrolled brain tumours
•6. Patients with brain tumours which have been treated but which have not been stable for 3 or more months
•7. Patients with known hypersensitivity to Hiltonol®, IL-2, Aldara®, cyclophosphamide (for patients 16 ? 30) or any of the excipients
•8. Any condition, which, in the opinion of the investigator might interfere with the safety of the patient or evaluation of the study objectives

发起方

St George's Healthcare NHS Trust (UK)