EUCTR2010-023124-24-NL进行中（未招募）1 期
Chemo-Immunotherapy, gemcitabine with pegylated interferon alpha-2b (Peg-Intron) with and without p53 synthetic long peptide (p53 SLP) vaccine, for patients with platinum resistant ovarian cancer.CHIP trial - CHIP trial
Academisch Ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum0 个研究点开始时间: 2010年11月4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
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 proven epithelial ovarian cancer, peritoneal cavity or fallopian tube cancer (inclusive mucinous or clear cell tumors)
- •Tumor expressing p53
- •Progression of disease or relapse after previous therapy with platinum
- •Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper limit of normal within 3 months and confirmed
- •Age =18 years
- •WHO performance status 0-2
- •Adequate bone marrow function: WBC =3.0 x 109/l, neutrophils =1.5 x 109/l, platelets =100 x 109/l
- •Adequate liver function: bilirubin =1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT =2.5 x UNL, Alkaline Phosphatase =5 x UNL
- •Adequate renal function: the calculated creatinine clearance should be =50 mL/min
- •Survival expectation > 3 months
- •Patients must be accessible for treatment and follow-up
- •Written informed consent according to the local Ethics Committee requirements
- •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
- •Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
- •Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- •Known hypersensitivity reaction to any of the components of the treatment
- •Pregnancy or lactating
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
研究者
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