EUCTR2013-003809-26-CZ进行中（未招募）1 期
Open-label, one-arm, multi-centre phase II clinical trial with second cycle of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy and without objective progression on the first cycle of DCVAC/PCa
SOTIO a.s.0 个研究点开始时间: 2013年10月4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) Signed informed consent to the study
- •Inc-2)Patients who were eligible and enrolled to Study SP003, received 10 doses of active cellular immunotherapy in Study SP003 and were without objective progression of the disease since the start of their participation in Study SP003
- •Inc-3) Time from the last dose of first-cycle active cellular immunotherapy of study SP003 is not longer than 16 weeks at the time of screening
- •Inc-4) The following laboratory values:
- •WBC > 4 x 10(9)/L, platelet count > 100 x 10(9)/L,
- •Hct > 30%, creatinine under 1.5 times the upper limit of normal,
- •bilirubin, AST and ALT under two times the upper limit of normal.
- •Inc-5) ECOG 0-2 Performance Status
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •E-1) Sexually active fertile men not using effective birth control, if their female partners are of fertile age and of child-bearing potential
- •E-2) Comorbidities of the patient:
- •E-2a) HIV positivity
- •E-2b) Active hepatitis B or C
- •E-2c) Active bacterial, viral or fungal infection requiring systemic treatment
- •E-2d) Clinically significant cardiovascular disease (including myocardial infarction or ventricular tachyarrhythmia within last 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 disorders) unless secured 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 intercurrent condition, uncompensated psychiatric illness or social situation that would limit patient’s compliance
- •E-2h) Patients with a history of malignancy other than non-melanoma skin cancer
- •E-2i) Unresolved clinically significant urinary tract obstruction
- •E-2j) Active autoimmune disease requiring therapy
- •E-2k) History of primary immunodeficiency
- •E-3) Allergies and adverse drug reactions
- •E-3a) History of allergic reaction to a compound of the same or similar structure as the investigational medicinal product
- •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) Any prostate cancer N and M stage other than N0 and M0
- •E-6) History of or ongoing androgen deprivation therapy after radical prostatectomy
- •E-7) History of or ongoing chemotherapy for prostate cancer
- •E-8) Immunotherapy other than specified in this protocol
- •E-9) Forbidden concomitant medication (other investigational drugs, products or instruments, any anti-tumour androgen deprivation therapy, bisphosphonate treatment)
- •E-10) Indication for radiotherapy during Study SP003 or screening period for Study SP010
研究者
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