NCT00844506已完成2 期
p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Clinical responses to the p53 synthetic long peptide vaccine preceded by cyclophosphamide will be assessed by measurement of serum CA-125 levels and CT-scan.
研究概览
简要总结
The purpose of this study is to determine whether the addition of cyclophosphamide to the treatment with the p53-SLP vaccine improves clinical efficacy and immunogenicity of the p53-SLP vaccine in ovarian cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Histological proven epithelial ovarian carcinoma.
- •At least 4 weeks after termination of the last course of chemotherapy.
- •Rising CA-125 serum levels after "first line" treatment and no measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria, or Rising CA-125 serum levels after "first line" treatment with measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria, but not willing or otherwise not fit to receive "second line" chemotherapy.
- •Age 18 years or older, and an life expectancy of at least 3 months.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •Performance status 0 to 2 (WHO scale).
- •Adequate hepatic, renal, and bone marrow function as defined:
- •ASAT < 100 U/l; ALAT < 113 U/l; PT 9-12 seconds; APTT 23-33 seconds; creatinine < 135 μmol/l; WBC > 3.0 x 109/L; platelets > 100 x 109/L; hemoglobin > 6.0 mmol/l.
- •Adequate venous access for blood collection and i.v. administration of cyclophosphamide.
排除标准
- •Pregnancy and / or breast feeding.
- •(A)symptomatic cystitis.
- •Other malignancies (previous or current), except basal or squamous cell carcinoma of the skin.
- •Immunosuppressive agents, except for topical and inhalation corticosteroids.
- •Prior therapy with a biological response modifier.
- •Any other major disease that may interfere with the conduct of the study (e.g. uncontrolled hypertension, severe and/or unstable heart disease, neurological and psychiatric disorders).
- •Signs or symptoms of CNS metastases.
- •Known substance abuse (drug or alcohol).
结局指标
主要结局
Clinical responses to the p53 synthetic long peptide vaccine preceded by cyclophosphamide will be assessed by measurement of serum CA-125 levels and CT-scan.
时间窗: day 105 - 126 after first gift of cyclophosphamide
Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT.
时间窗: after fourth immunization
次要结局
- Safety of the vaccine preceded by cyclophosphamide will be assessed by monitoring the incidence and severity of adverse events using Common Terminology Criteria for Adverse Events v3.0.(durante study)
研究者
研究点 (2)
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