EUCTR2012-002411-26-NO进行中（未招募）不适用
A PHASE I/IIA STUDY OF UV1 VACCINATION IN PATIENTS WITH HORMONE-SENSITIVE METASTATIC PROSTATE CANCER.
Oslo University Hospital0 个研究点开始时间: 2012年9月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •Patients with advanced oligometastatic prostate cancer (PCa) without lung and/or liver metastases who are eligible to Complete Androgen Blockade (GnRH-agonist combined with anti-androgen)
- •Patients already on GnRH-agonist must have a history sPSA < 200 ng/mL prior to start of GnRH-agonist treatment. GnRH-agonist with or without bicalutamide can have been initiated up to 6 months prior inclusion.
- •Must be ambulatory with an ECOG performance status of 0 or 1
- •Must be at least 18 years of age.
- •Must have lab values as follows:
- •- White Blood Cells >= 1.5 x 109/L
- •- Platelets >= 100 x 109/L
- •- Hemoglobin >= 9g/dL (>=5.6 mmol/L)
- •- Creatinine <= 140 µmol/L
- •- Bilirubin < 20% above the upper limit of normal
- •- ASAT and ALAT <=1.5 the upper limit of normal
- •- Albumin >= 2.5 g/L
- •- Normal NSE
- •- sPSA < 200 ng/mL.
- •Signed informed consent
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
- •Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug.
- •Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
- •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome.
- •Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- •Active infection requiring antibiotic therapy.
- •Known sensitivity to any of the components of the vaccine
- •Known hypersensitivity to Leukine®, yeast derived products or any component of the product
- •Patients who test positive for hepatitis B, C or HIV.
- •Any other anti-tumor treatment (including chemotherapy, immunotherapy, cytokines, interferons, protease inhibitors and gene therapy) administered with the exception of GnRH-agonist with or without bicalutamide started up to 6 months prior inclusion.
- •Use of not permitted concomitant medication:
- •- chronic corticosteroids except for asthma inhalers / topical use
- •- any alternative and complementary drugs.
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究者
相似试验
进行中（未招募）
1 期
PHASE I/IIa STUDY OF VACCINE THERAPY IN PATIENTS WITH NON-SMALL CELL LUNG CANCEREUCTR2012-001852-20-NOOslo University Hospital21
进行中（未招募）
不适用
Phase I/II trial of vaccine therapy in patients with recurrent ovarian cancer.Relapsed and platinum resistant epithelial ovarian carcinoma patients that have received one line of non-platinum chemotherapy in resistance disease setting.EUCTR2010-020233-56-NOOslo University Hospital20
招募中
1 期
A phase Ia /Ib study of vaccination with NY-ESO-1 protein, Poly ICLC and mogamulizumab in patients with Adult T cell leukemia/lymphoma expressing NY-ESO-1 antigeAdult T cell Leukemia/LymphomaJPRN-UMIN000017748Osaka University Graduate School of Medicine30
招募中
1 期
Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.Breast CancerJPRN-UMIN000002408Department of Breast and Endocrine Surgery, Juntendo University School of Medicine6
已完成
1 期
Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.on-Small-Cell Lung CancerJPRN-UMIN000002141Department of Respiratory Medicine, Juntendo University School of Medicine9