EUCTR2014-000095-26-IT进行中（未招募）1 期
A randomised, parallel-group, open-label Phase II trial of the immunological effects of three regimens of GX301 vaccination in castration-resistant prostate cancer patients who have achieved response to first-line chemotherapy.
aboratoires Leurquin Mediolanum S.A.S.0 个研究点目标入组 120 人开始时间: 2014年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •Patient history
- •Eligible patients will have a documented history of the following:
- •? Histologically confirmed diagnosis of prostate cancer, with an available Gleason score.
- •? Diagnosis of progressive, castration-resistant prostate cancer (CRPC), leading to inception of first-line chemotherapy with a docetaxel-based regimen.
- •CRPC is defined as progression in PSA levels and/or in bone lesions or soft-tissue (visceral, nodal) lesions that has occurred during therapy with: front-line concurrent LHRH agonist and anti-androgen (maximal androgen blockade); or an anti-androgen added to front-line LHRH agonist following failure of the latter; or an LHRH-agonist replacing, or added to, front-line anti-androgen following failure of the latter.
- •Progression must have been observed: in all cases, in the presence of castrate serum testosterone levels (=50 ng/dL or 1.7 nmol/L); in patients receiving anti-androgen therapy, following 6 or more weeks from discontinuation of the anti-androgen agent.
- •? Completion of chemotherapy with a cumulative delivered dose of 300 to 825 mg/m2 docetaxel.
- •Current patient status
- •? Age =18 years.
- •? Ability to understand study-related patient information and provision of written informed consent for participation in the study.
- •? Symptomatic or asymptomatic status (as for cancer-related symptoms).
- •? ECOG performance status of 0 or 1.
- •? Life expectancy of at least 6 months.
- •? An interval =4 weeks elapsed from the last docetaxel administration.
- •? Documented response to docetaxel chemotherapy. This is defined as post-chemotherapy PSA and imaging findings showing all of the following, as compared with the pre-chemotherapy documentation:
- •a) a PSA decrease =50% confirmed in two consecutive determinations obtained approximately 4 weeks apart;
- •b) absence of new bone lesions at radionuclide bone scan;
- •c) a status of soft-tissue (nodal, visceral) lesions meeting RECIST criteria for complete response or partial response.
- •? Current castrate testosterone level (=50 ng/dL or 1.7 nmol/L) due to current GnRH agonist or antagonist therapy or past orchiectomy.
- •? Withdrawal of antiandrogen therapy, if any, for at least 4 weeks prior to randomization.
- •? Haematology and blood chemistry values (central laboratory) complying with the following criteria:
- •- Total WBC count ? 3.0x109/L (to ensure that of a sufficient number of lymphocytes are available for the immunological tests)
- •- Platelets ? 100x109/L
- •- Serum bilirubin ?1.5 times the upper normal limit (UNL)
- •- Alkaline phosphatase ? 3.0 times the UNL
- •- AST and ALT ? 2.5 times the UNL
- •- Creatinine ?1.5 mg/dL (133 µmol/L).
- •? Successful recovery from all acute toxicities from prior chemotherapy (except alopecia, grade 2 peripheral neuropathy and change in nails).
- •? Confirmation from the immunology laboratory that the blood sample provided for baseline immunological tests is technically adequate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •? Known intolerance to Montanide or imiquimod. Montanide adjuvants are found as ingredients of experimental human vaccines. Imiquimod is the active ingredient of Aldara, a medicinal product for topical use.
- •? Known presence of brain metastatic disease or spinal cord compression.
- •? Radiotherapy within the past 4 weeks.
- •? Concomitant presence of other primary malignancy except for non-melanomatous skin cancer, unless it was diagnosed and successfully treated = 5 years ago with no subsequent evidence of recurrence.
- •? Major surgery within 4 weeks prior to randomisation.
- •? Cardiovascular illness or complication which, in Investigator’s judgment, compromises prognosis at 6 months or prevents the patient from following study procedures, including a recent history of stroke or myocardial infarction or presence of NYHA class III-IV heart failure or severe arrhythmia.
- •? Serious (NCI CTCAE grade 3-4) uncontrolled infection.
- •? Known presence of active autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's Disease, multiple sclerosis, ankylosing spondylitis).
- •? Known presence of acquired, hereditary, or congenital immunodeficiency, (e.g. cellular immunodeficiencies, hypogammaglobulinemia, dysgammaglobulinemia).
- •? HIV infection.
- •? Current need for immunosuppressive drug therapy, including systemic corticosteroids. Previously exposed patients are eligible following a wash-out period =4 weeks before randomisation.
- •? Current need for denosumab therapy. (Patients under bisphosphonate treatment are eligible).
- •? Skin disease interfering with evaluation of local tolerance of GX301 injections.
- •? Any condition which, in the judgment of the Investigator, would place the subject at undue risk or interfere with the results of the study.
- •? Inability to regularly access centre facilities for logistical or other reasons.
- •? Participation in any interventional drug or medical device study within 30 days prior to treatment start.
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