EUCTR2011-004986-34-CZ进行中（未招募）1 期
Randomized, open-label, parallel-group, multi-centre phase II clinical trial with active cellular immunotherapy DCVAC/PCa in combination with hormone therapy in patients with metastatic prostate cancer - not applicable
SOTIO a.s.0 个研究点开始时间: 2011年11月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
- •Inc-1) Men aged = 18 years
- •Inc-2) Histologically confirmed prostate carcinoma
- •Inc-3) Bone or soft-tissue (other than brain or leptomeningeal) metastases confirmed by CT of the abdomen and small pelvis and/or bone scintigraphy
- •Inc-4) The androgen deprivation therapy with LHRH analogs started not less than 1 month and not more than 3 months prior to the screening, or orchiectomy performed not less than 1 month and not more than 3 months prior to the screening
- •Inc-5) ECOG 0-2 Performance Status
- •Inc-6) The following laboratory values: WBC > 4 x 10(9)/L, ANC = 1.5 x 10(9)/L, platelet count > 100 x 10(9)/L, Hb = 90 g/L, Hct > 30%, Creatinine under 1.5 times the upper limit of normal, bilirubin, AST and ALT under 1.5 times the upper limit of normal.
- •Inc-7) Castrate level of serum testosterone at screening (= 1.7 nmol/L, or = 50 ng/dL)
- •Inc-8) Signed informed consent to participate in the study
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •E-1) Sexually active fertile men not using effective birth control, if their partners are of fertile age and of child-bearing potential
- •E-2) Comorbidities of the patient
- •E-2a) HIV-positive
- •E-2b) Active hepatitis B or C
- •E-2c) Active bacterial, viral or mycotic infection requiring systemic treatment
- •E-2d) Clinically significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia in previous 6 months, percutaneous coronary intervention or surgical revascularization in the past 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction problems, unless treated with permanent cardiac pacing.
- •E-2e) Pleural or pericardial effusion of any CTC grade
- •E-2f) Peripheral neuropathy CTC Grade = 2.
- •E-2g) Other uncontrolled coexisting condition, uncompensated psychiatric illness or social situation that would limit patient’s compliance.
- •E-2h) Patients with a history of second malignancy other than non-melanoma skin cancer.
- •E-2i) Unresolved ongoing clinically significant urinary tract obstruction
- •E-2j) Active autoimmune disease requiring therapy
- •E-2k) History of primary immunodeficiency
- •E-3) Allergy and adverse drug reactions
- •E-3a) History of allergic reaction to a compound of the same or similar structure as medication used in this study.
- •E-3b) History of anaphylaxis or other severe reaction following vaccination
- •E-4) Any other serious reason the Investigator considers the patient should not participate in the study
- •E-5) History of or ongoing chemotherapy for prostate cancer
- •E-6) Patients with brain metastases or leptomeningeal metastases
- •E-7) Ongoing unresolved post-operative complication of orchiectomy, which either requires treatment or restricts patient’s everyday activities
- •E-8) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening
- •E-9) Immunotherapy other than specified in this protocol
- •E-10) Prohibited concomitant medication
研究者
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