A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose- limiting toxicity (DLT)
研究概览
简要总结
This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be planning to receive standard of car e neoadjuvant chemotherapy as defined by the most recent version of NCCN guidelines (www.nccn.org)
- •Patients must have histologically or cytologically confirmed invasive breast cancer that is either triple-negative or HER2+ (regardless of hormone receptor status)
排除标准
- •Patients with any uncontrolled intercurrent illness.
- •Patients who have any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant
- •History of egg allergy
- •Patients currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the seasonal flu vaccine.
- •History of Guillain-Barré syndrome
研究组 & 干预措施
Intratumoral influenza vaccine
干预措施: Fluzone Quadrivalent (Biological)
结局指标
主要结局
Dose- limiting toxicity (DLT)
时间窗: 3 months post surgery
The primary objective of this trial is to assess the safety of intratumoral (IT) influenza vaccine administration in patients with breast cancer receiving neoadjuvant chemotherapy, by evaluating the percentage of patients experiencing dose- limiting toxicity (DLT).
次要结局
未报告次要终点
研究者
Ruta Rao
Study Principal Investigator
Rush University Medical Center