ACTRN12612001101875进行中（未招募）1 期
A phase I/II trial of immunisation with autologous dendritic cells loaded with NY-ESO-1 and Alpha-galactosylceramide in patients with high-risk surgically resected stage II, III or IV melanoma
Malaghan Institute of Medical Research0 个研究点目标入组 46 人开始时间: 2012年10月16日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients must meet all the following criteria to be considered for inclusion in this study:
- •1. Able to give written informed consent and aged 18 years or over.
- •2. Histologically proven, fully resected American Joint Committee on Cancer (AJCC) Stage II, III, IV malignant cutaneous melanoma.
- •3. Full recovery from surgery (a minimum of 2 weeks should have elapsed since most recent surgery).
- •4. The patient must have been rendered disease free for no more than 12 months from surgery before study treatment.
- •5. ECOG performance status less than or equal to 2.
- •6. Geographically accessible to the Wellington Blood and Cancer Centre (WBCC) or prepared to travel regularly to Wellington for treatment and follow-up for the duration of the study.
- •7. Patients must have normal haematological, liver or renal parameters as indicated by:
- •i) Haemoglobin > 100 g/L
- •ii) Platelet count > 100 x109/L
- •iii) Neutrophil count > 1.5 x 109/L
- •iv) Lymphocytes > or = 0.8 x 109/L
- •v) Alanine Transaminase (ALT) less than or equal to 2.5 Upper Limit of Normal (ULN)
- •vi) Alkaline Phosphatase (ALP) less than or equal to 2.5 ULN
- •vii) Bilirubin less than or equal to 1.5 ULN
- •viii) Creatinine < 1.5 x ULN
- •8. If childbearing potential female, prepared to use contraception for the duration of the trial. Postmenopausal status is defined as meeting one or more of the following criteria:
- •i) over the age of 60
- •ii) bilateral oophorectomy
- •iii) aged up to and including 60 years of age with a uterus and amenorrhoea for at least 12 months
- •iv) aged up to and including 60 years of age without a uterus and with Follicle-stimulating hormone (FSH) >30 IU/L
排除标准
- •Patients presenting with any of the following criteria are excluded from this study:
- •1. Mucosal or ocular melanoma.
- •2. Prior chemotherapy or radiotherapy for advanced melanoma within 6 weeks of randomisation to the study.
- •3. Received any prior immune therapy.
- •4. Pregnant or breastfeeding women.
- •5. Diagnosis of any other previous cancer in the past 5 years (except non-melanoma skin cancer or in situ cancer of the cervix).
- •6. Serology indicating active infection with Hepatitis B, C or Human immunodeficiency virus (HIV.)
- •7. Uncontrolled or unstable autoimmune disease such as Systemic Lupus Erythematosus (SLE), sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis
- •8. Previous use of long-term immunosuppressive therapy in recent months. Must have three months off steroids before entry into the study.
- •9. Patients with co-morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment (e.g. chronic obstructive pulmonary disease [COPD]). Steroid use less than or equal to 1 month is permissible.
- •10. Concurrent major organ dysfunction or unstable medical condition.
- •11. Unable to comply with study requirements as judged by the investigator.
研究者
相似试验
进行中（未招募）
1 期
A Study of Safety and Clinical Activity of Cancer Immunotherapy Plus Chemotherapy in Metastatic Melanoma PatientsPatients with unresectable and progressive metastatic cutaneous melanoma, whose tumor expresses MAGE-A3.MedDRA version: 16.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864EUCTR2008-001918-25-BEGlaxoSmithKline Biologicals40
进行中（未招募）
1 期
A Study of Safety and Clinical Activity of Cancer Immunotherapy Plus Chemotherapy in Metastatic Melanoma PatientsEUCTR2008-001918-25-FRGlaxoSmithKline Biologicals48
未知
1 期
Phase I/II study of adoptive immunotherapy using cytotoxic T cells specific for minor histocompatibility antigen restricted to hematopoietic cells for patients with high-risk leukemia that relapsed following allogeneic hematopoietic stem cell transplantatio1) RAEB, CMML 2) AML or ALL in induction failure or beyond first remission 3) Ph/p190-positive ALL at any stage 4) imatinib-resistant CMJPRN-C000000162Aichi Cancer Center30
进行中（未招募）
不适用
An open Phase II study of immunization with the recMAGE-A3 + AS01B Antigen-Specific Cancer Immunotherapeutic in patients with MAGE-A3-positive unresectable and progressive metastatic cutaneous melanoma. - MAGE3-AS01B-MEL-001 (MET)MAGE-A3-positive unresectable and progressive metastatic cutaneous melanoma.EUCTR2007-005203-18-GRGlaxoSmithKline Biologicals34
已完成
不适用
A safety and immunogenicity phase 1 trial with an adjuvated TB subunit vaccine (Ag85B - ESAT-6 + IC31) administered in PPD positive volunteers at 0 and 2 monthsPrevention10028440TuberculosisNL-OMON30684Statens Serum Institut20