EUCTR2011-004735-32-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 patients with castrate-resistant prostate cancer - not applicable
SOTIO a.s.0 个研究点开始时间: 2011年10月21日最近更新:
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
- •I-1) Men aged = 18 years
- •I-2) Histologically confirmed prostate cancer
- •I-3) Presence of metastatic bone disease according to at least one of the following modalities: bone scan (scintigraphy, PET-CT), confirmed pathological fracture, evidence of bone metastases confirmed by MRI or CT
- •I-4) Presence of progression defined as at least one of the following:
- •I-4a) PSA level increasing by at least 2 ng/mL at an interval of at least 14 days with an absolute value = 5 ng/mL and = 50% above the PSA minimum reached during the ADT (androgen deprivation therapy) or above the level prior to treatment, if there was no response.
- •I-4b) Two or more new lesions discovered on the bone scan or CT or MRI as compared with the preceding scan
- •I-5) Continuing castrate condition: Patients who did not undergo surgical orchiectomy have to continue hormone drug therapy (GnRH/LHRH analogs) to maintain the castrate level of serum testosterone = 1.7 nmol/l (50 ng/dl). The castrate condition has to be at least 3 months before enrolment to the study and continue for the study duration.
- •I-6) The following laboratory values: WBC > 4 x 10(9)/L, ANC = 1.5x 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.
- •I-7) ECOG 0-2 Performance Status
- •I-8) Signed informed consent to participate in the study
- •I-9) Recovery from primary local surgery, radiotherapy or orchiectomy.
- •I-10) At least 8 weeks from radioisotope therapy (Samarium-153, Strontium -89 or similar)
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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 malignancy other than non-melanoma skin cancer.
- •E-2i) Unresolved ongoing 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) Patients already treated with chemotherapy for prostate cancer (except estramustine)
- •E-6) Patients with brain and leptomeningeal metastases
- •E-7) Participation in another clinical trial or administration of another investigational medicinal product within 30 days preceding the screening
- •E-8) Treatment with antiandrogens, inhibitors of adrenal androgen production, or any other anti-tumor hormone therapy ongoing on the day of screening or in preceding 4 weeks except GnRH/LHRH analogs
- •E-9) Immunotherapy other than specified in this protocol
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