A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Occurrence of Related Adverse Events (AEs)
研究概览
简要总结
The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.
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
- •Women >= 18 years.
- •Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with positive margins.
- •Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS during vaccinations.
- •Women of childbearing age with a negative pregnancy test documented prior to enrollment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or
- •Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
- •Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
- •Exclusion Criteria
- •Pregnant or lactating.
- •Positive for HIV or hepatitis C at baseline by self-report.
- •Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec
- •Major cardiac illness MUGA or ECHO <50% EF.
- •Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
排除标准
- 未提供
研究组 & 干预措施
Combination Therapy
Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
干预措施: HER-2 pulsed DC1 (Biological)
Combination Therapy
Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
干预措施: trastuzumab (Drug)
Combination Therapy
Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
干预措施: pertuzumab (Drug)
结局指标
主要结局
Occurrence of Related Adverse Events (AEs)
时间窗: 5 years
Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.
次要结局
未报告次要终点