EUCTR2014-004420-22-IE进行中（未招募）1 期
Enhancing malignant melanoma immunological engagement using sequential therapy with ipilimumab and electrochemotherapy - EMMIE-IP
niversity College Cork0 个研究点目标入组 10 人开始时间: 2015年1月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- •1.Histologically verified melanoma.
- •2.Patient must have a node/cutaneous lesion which is amenable to ECT.
- •3.Patient must have at least one measurable lesion on a CT scan as defined by Modified RECIST.
- •4. Unresectable, locally advanced, or metastatic melanoma with disease progression and no curable options with the standard of care.
- •5.Men or women aged at least 18 years.
- •6.Life expectancy of at least 3 months.
- •7.Performance status (ECOG < or equal to 2).
- •8.Treatment free interval of at least 2 weeks after previously applied therapy.
- •9.WBC greater than or equal to 4.4 x 10 ^9/L, ANC great than or equal to 1.4x 10^9/L
- •10.Platelets greater than or equal to 140 x 10^9/L
- •11.Hemoglobin greater than or equal to 9g/dL
- •12.Serum creatinine less than or equal to 1.5 times the upper limit of normal or creatinine clearance greater than or equal to 40 mls/min (using the Cockcroft-Gault Equation)
- •13.AST and ALT less than or equal to 3 times ULN or less than or equal to 5 times ULN for subjects with liver metastasis
- •14.Total bilirubin: less than or equal to 3 x ULN, [except subjects with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/dL]
- •15.Patients must not have any physical, social or psychological condition that in the opinion of the investigator would impair the patients ability to provide informed consent.
- •16.a) A female of Non-Childbearing potential (i.e. physiologically incapable of becoming pregnant) is eligible to participate in the study if she:
- •- has had a hysterectomy
- •- has had a bilateral oophorectomy (ovariectomy)
- •- has had a bilateral tubal ligation
- •- Is post-menopausal:
- •[Post Menopausal definition: Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for = 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an oestradiol value < 40pg/mL (<140 pmol/L).
- •Patients using HRT must have experienced total cessation of menses for > or = 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and oestradiol concentrations prior to initiation of HRT.]
- •b) A female of Childbearing potential is eligible to participate in the study only if she has had a negative serum or urine pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible.
- •c) Women of Childbearing potential and Men must agree to use adequate contraception since signing of the informed consent form until at least 6 months after the last study drug administration. The investigator or a designated associate is requested to advise the patient how to achieve an adequate birth control.
- •18. Subjects with brain metastasis are eligible if these have been treated and there is no MRI (MRI -except where contraindicated in which case CT Scan is acceptable) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior or the first dose of study drug administration. There must be no requirement for immunosupressive doses of systemic corticosteroids (>10mg/day prednisolone equivalents) for at least 2 weeks prior to study drug administration.
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Coagulation disorder
- •2.Patients with a clinically manifested arrhythmia or with a pacemaker
- •3.Patients with epilepsy.
- •4.Pregnancy or lactation/breastfeeding.
- •5.History of or current active autoimmune diseases, [e.g. including but not limited to inflammatory bowel diseases [IBD], rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barre syndrome). Vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are not exclusionary.]
- •6.No known active infectious disease including including HIV, HBV and HCV.
- •7.Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation.
- •8.History of or current immunodeficiency disease [e.g. splenectomy or splenic irradiation];
- •9.Prior allogeneic stem cell transplantation;
- •10.Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
- •11.Concomitant therapy [e.g.: anti-cancer agent, potent immunosuppressive agents, surgery or radiotherapy or other investigational anti-cancer therapies or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses) with the exception of low dose steroids for AE management as deemed clinically appropriate.
- •12.Prior therapies with systemic immunosuppressive agents [within prior 2 years (excluding episodic low dose corticosteroids, eg, for treatment of allergic dermatologic conditions); prior therapies with cytotoxic or investigational drugs within 2 weeks of randomization;]
- •13.Prior immunotherapy within the previous 4 weeks.
- •14.Treatment with any other investigational products/chemotherapy/RT, etc. within 2 weeks prior to inclusion into this study.
- •15.Participation in another clinical study.
- •16.Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
- •17.Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease.
- •18.Contraindication for bleomycin use: allergic reactions to bleomycin observed in previous treatment.
- •19.Contraindication for bleomycin use: if cumulative dose of 250mg BLM/m2 was previously exceeded.
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