EUCTR2010-018770-20-NO进行中（未招募）不适用
Phase I/II trial of vaccine therapy in curative resected prostate cancer patients using autologous dendritic cells loaded with mRNA from primary prostate cancer tissue, hTERT and surviving.
Oslo University Hospital0 个研究点目标入组 30 人开始时间: 2010年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Radical prostatectomy with negative resection margins. Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA).
- •Pathological stage pT2 - pT3b and Gleason score 7B-10, pN0, pN+ or pNx.
- •Must be ambulatory with an ECOG performance status 0 or 1.
- •Tumor cells detected in bone-marrow samples (micrometastatic disease). Patients with Gleason score 9-10 may also be included with negative bone-marrow aspiration. Bone-marrow aspirates and plasma for microRNA will be obtained before start of surgery.
- •Must be at least 18 years of age and less than 75 years.
- •PSA < 0.2µg/L within 6 weeks after surgery.
- •Must have lab values as the following:
- •ANC = 1.5 x 109/L
- •Platelets = 100 x 109/L
- •Hb = 9 g/dL (= 5.6 mmol/L)
- •Creatinine = 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance = 40 mL/min
- •Bilirubin within the upper limit of normal
- •ASAT and ALAT = 2.5 the upper limit of normal
- •Albumin levels above lower normal value
- •No metastasis on bone scans or MRI, last 3 months before inclusion.
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous treatment with LHRH agonist.
- •Previous anti-androgen treatment (Casodex).
- •History of prior malignancy within the last 5 years, with the exception of curatively treated basal cell carcinoma.
- •Active infection requiring antibiotic therapy.
- •Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- •Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
- •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
- •Use of systemic glucocorticoids.
- •Negative testing for HIV, Hepatitis B and C
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究者
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