An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 12
- 主要终点
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.
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
- •Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003
- •Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have available Cvac doses)
- •Were enrolled in CAN-003 and met protocol criteria for progressive disease
- •Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk
- •Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion
- •Able to provide written informed consent
- •White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL, hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm^3
排除标准
- •Pregnant or breastfeeding
- •Other medical conditions which preclude study participation, in the opinion of the investigator
- •Receiving treatment with any other investigational product
研究组 & 干预措施
Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
干预措施: MUC1 Dendritic Cell Vaccine (Cvac) (Biological)
结局指标
主要结局
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
时间窗: First dose of study vaccine to 30 days past last dose (Approximately 1 Year)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
次要结局
未报告次要终点