EUCTR2008-003967-37-DE进行中（未招募）不适用
Safety and efficacy trial of a RNActive®-derived prostate cancer vaccine in hormone refractory disease
CureVac GmbH0 个研究点目标入组 50 人开始时间: 2008年7月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •1. Signed informed consent in accordance with GCP and local regulatory
- •requirements prior to trial participation
- •2. Male and age = 18 yrs (Phase I and II) and = 75 yrs (Phase II only)
- •3. Histologically confirmed diagnosis of adenocarcinoma of the prostate,
- •Gleason Score available
- •4. Patients must have been treated with hormonal therapy and may have been
- •treated with surgery and/ or radiation therapy
- •5. Progressive disease as defined by hormone-refractoriness and rise in PSA:
- •Hormone refractoriness: Defined by a rise in PSA and/or RECIST-based
- •progression of evaluable lesions, and/or increased number of hotspots on
- •a bone scan, while the patient has a castrated level of testosterone. This
- •castrated level may have been obtained by orchiectomy, or LH-RH
- •analog ± antiandrogen. Antiandrogen must be discontinued for at least 4
- •weeks before study entry to exclude a withdrawal effect.
- •Rise in PSA: Defined by a rise in PSA levels at three consecutive time
- •points (PSA rise over nadir, separated by > 1 week, PCWG2 criteria)
- •6. Presence of metastatic disease is acceptable
- •7. ECOG performance status of 0 to 1
- •8. Life expectancy > 12 months as assessed by the investigator
- •9. Adequate organ function
- •Bone marrow function: Hemoglobin = 10 g/ dL; Leukocytes = 3000/ µL;
- •Lymphocytes = 1000/ µL; Absolute neutrophil count = 1500/ µL; Platelet
- •count = 100000/ µL
- •Hepatic: AST and ALT = 2.5 times upper limit of normal (ULN);
- •Bilirubin = 1.5 ULN
- •Renal: Creatinine = 1.5 mg/ dL or creatinine clearance = 60mL/ min
- •10. Concomitant LH-RH therapy continuation is acceptable11. May have had local palliative radiotherapy for bone metastasis involving less
- •than 25% of bone marrow
- •12. Patients requiring bisphosphonates at the time of registration into the trial are
- •eligible (therapy initiated at least 28 days prior to first study treatment
- •administration) and must be continued at a constant level during the study
- •13. Patients of child-producing potential must agree to use contraception while
- •enrolled in the study and for one month after the last immunization.
- •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
- •The following are criteria for exclusion of patients from participating in the study:
- •1. Other histologic type of prostate cancer (transitional cell, small cell or
- •squamous cell cancer)
- •2. Symptomatic brain metastasis or leptomeningeal involvement
- •3. Patients having received or currently receiving chemo- or biological
- •therapy for prostate cancer
- •4. Symptomatic congestive heart failure (NYHA 3 and 4); unstable angina
- •pectoris; significant cardiac arrhythmia
- •5. Pulmonary disease causing dyspnea or fatigue during normal activity
- •6. History of seizures, encephalitis or multiple sclerosis
- •7. Inflammatory bowel disease e.g. Crohn’s disease or ulcerative colitis; active
- •diverticulitis
- •8. Documented history of active autoimmune disorders requiring systemic
- •immunosuppressive therapy, (e.g. sarcoidosis, lupus erythematosus,
- •rheumatoid arthritis, glomerulonephritis or systemic vasculitis), excepting
- •autoimmune thyroiditis with only thyroid hormone replacement and stable
- •disease > 1 year
- •9. Primary or secondary immune deficiency
- •10. History of allergy requiring medication
- •11. Active drug abuse or chronic alcoholism
- •12. Clinically significant active infections
- •13. Seropositive for HIV, HBV or HCV
- •14. History of other malignancies over the last 5 years (except basal cell
- •carcinoma of the skin)
- •15. Uncontrolled medical condition considered as high risk for the treatment with
- •an investigational drug including unstable diabetes mellitus, vena-cavasyndrome,
- •known ascites and/or pleural effusion, symptomatic pleural
- •effusion treated by puncture
- •16. Renal insufficiency requiring dialysis
- •17. Patients being committed to an institution by virtue of an order issued either
- •by the judicial or the administrative authorities.
研究者
相似试验
尚未招募
1 期
A clinical trial for the efficacy and safety of new Chinese herbal compound in reducing uric acid in patientsHyperuricemiaITMCTR2000003495Tongren of Traditional Chinese Medicine
已完成
1 期
Phase I/II study on the safety and efficacy of repeated administration of FIT039 transdermal patch for verrucas caused by human papilloma-virusPhase I/II study on the safety and therapeutic efficacy of repeated administration of FIT039 transdermal patch on verrucas caused by human papillomavirusJPRN-UMIN000029695Department of Dermatology, Kyoto University Hospital44
尚未招募
2 期
EFFECT OF PRADHAMANA NASYA AND NARADIYA LAXMIVILAS RASA FOR THE MANAGEMENT OF PATIENTS SUFFERING FROM KAPHAJA PRATISYAYACTRI/2022/02/040162All India Institute of Ayurveda
已完成
1 期
A clinical trial of influenza(H1N1) vaccine (Live attenuated) in Adults.CTRI/2010/091/000008Serum Institute of India Limited50
进行中（未招募）
不适用
Clinical study to evaluate safety and efficacy of an RNA active vaccine against non-small cell lung cancer in stage IIIB/IVEUCTR2008-007785-39-DECureVac GmbH46