EUCTR2010-020233-56-NO进行中（未招募）不适用
PHASE I/II TRIAL OF VACCINE THERAPY IN RELAPSED AND PLATINUM RESISTANT EPITHELIAL OVARIAN CANCER PATIENTS USING AUTOLOGOUS DENDRITIC CELLS LOADED WITH AMPLIFIED OVARIAN CANCER STEM CELL mRNA, hTERT mRNA AND SURVIVIN mRNA. - DC vaccine ovarian cancer
Oslo University Hospital0 个研究点目标入组 20 人开始时间: 2011年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- Female
入选标准
- •Histologically confirmed epithelial ovarian cancer. Histologic documentation of the original primary tumor is required via pathology report.
- •Completed first line treatment (surgery and adjuvant or neoadjuvant treatment with carboplatine and paclitaxel)
- •Residual tumor =1 cm after primary surgery
- •Relapsed and platinum resistant epithelial ovarian carcinoma patients that have received one line of non-platinum chemotherapy in resistance disease setting.
- •Start of vaccine therapy within 4-6 weeks after end of last chemotherapy regimen.
- •If surgery is indicated, the patient should be surgically treated and then starts vaccination with a minimum interval of 28 days.
- •Must be ambulatory with an ECOG performance status 0 or 1.
- •Life expectancy = 6 months
- •Must be of 18-75 years of age
- •Must have lab values as the following:
- •-ANC = 1.5 x 109/L
- •-Platelets = 100 x 109/L
- •-Hb = 9 g/dL (= 5.6 mmol/L)
- •-Creatinine = 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance = 40 mL/min
- •-Bilirubin within the upper limit of normal
- •-ASAT and ALAT = 2.5 the upper limit of normal
- •-Albumin levels above lower normal value
- •If the patient has preserved fertility after primary treatment, she must practice adequate contraception during the study treatment
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.
- •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 10
排除标准
- •Eligible to otherwise curative treatment.
- •History of prior malignancy, other than ovarian cancer, within the last 5 years, with the exception of curatively treated basal cell carcinoma and cancer in situ cervix uteri.
- •Prior surgery within the past 28 days
- •Symptoms of the recurrent disease that can be treated by chemotherapy.
- •Active infection requiring antibiotic therapy.
- •Have known active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis). Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis.
- •Significant cardiac or other medical or mental illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, serious cardiac arrhythmia or psychosis.
- •Pregnancy or lactation
- •Previous adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
- •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
- •Positive for HIV, Hepatitis B and C tests
- •Use of systemic glucocorticoids.
- •Prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents stopped for less than 4 weeks before first study treatment administration. Anti hormonal treatment, such as Tamoxifen, may continue until first study treatment administration.
- •Previous treatment with dacarbazin or temozolomide at any time prior to study entry
- •Any reason why, in the opinion of the investigator, the patient should not participate
研究者
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