Type I Interferon Alfa-2a in Postmastectomy Breast Reconstruction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
RATIONALE: Implant-based reconstruction have become the most popular choices of reconstruction for women undergoing breast mastectomy. Postoperative complications like infection and tumor recurrence limit its application. Interferons (IFNs) are pleiotropic cytokines that involve in immunoregulatory, anticancer and restricting infection. Especially, type I IFN signaling is reported favourable for the success of conventional chemotherapeutics, radiotherapy and immunotherapy. In addition, type I IFN can regulate the activity of almost all immune cell types (including T cells, macrophages and innate lymphocytes), creating a well-established immune environment to defense infectious and relapsing disease. Implants are rapidly coated with extracellular matrix proteins and immune protein components for the formation of a typical capsule. At the specific time point before implantation, the locally utilized of IFN in intracavity breast is assumed to modify cellular immune responses thus contributing to decreasing infection and tumor recurrence.
PURPOSE: This non-randomized phase I trial aims to explore dose range of IFNα-2a. Adverse events are observed to assess drug safety and human tolerance index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent.
- •Female aged between 18 and 70 years.
- •Pathologically diagnosed operable breast cancer.
- •WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Newly diagnosed breast cancer.
- •The important organ functions meet the following criteria:
- •WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;
- •Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
- •Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min;
- •Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);
- •LVEF basement >= 50%.
排除标准
- •Evidence of distant metastasis.
- •Any contraindication of nipple-areolar complex (NAC) saving mastectomy (NSM):
- •Intraoperative biopsy revealed carcinoma invasion of NAC.
- •Paget's disease of breast.
- •Tumor distant from NAC less than 1 cm.
- •Any invasive malignancy diagnosed within previous 5 years (other than successfully treated cervical carcinoma in situ, skin basal cell carcinoma or cutaneous squamous cell carcinoma).
- •At least 4 months since prior interferon therapy.
- •At least 3 weeks since prior major surgery requiring general anesthesia.
- •At least 3 weeks since prior radiotherapy or chemotherapy.
- •Hypersensitivity to interferon or other components: urticaria, angioedema, bronchial stenosis, anaphylaxis, or Stevens-Johnson syndrome.
- •Prior organ allograft.
- •Use of an unlicensed or other investigational drug within 4 weeks.
- •Any severe comorbidities, inability to give informed consent or unavailability for follow-up, including but not limited to any of the following:
- •Heart failure above NYHA class 2 level; high-risk uncontrollable arrhythmia; unstable angina pectoris; myocardial infarction within 1 intervention.
- •Chronic obstructive pulmonary disease requires treatment.
- •Chronic liver disease (cirrhosis, chronic active hepatitis, etc.).
- •Cerebrovascular accident occurred within 6 months.
- •Severe epilepsy or central nervous system diseases.
- •Hypertension which cannot be well controlled by antihypertensive drugs.
- •Abnormal coagulation, bleeding tendency, or receiving thrombolysis or anticoagulant therapy.
- •Chronic renal insufficiency.
- •Active infection.
- •Psychiatric disability, etc.
- •Pregnant or lactating women.
研究组 & 干预措施
Experimental: Participants with breast cancer enrolled in grou
干预措施: IFNα-2a (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 7 days after surgery
Dose-limiting toxicity (DLT), defined as certain grade II toxicity such as nephrotoxicity and cardiotoxicity, grade III non-hematologic toxicity and grade IV hematologic toxicity.
Maximal tolerable dose (MTD)
时间窗: 7 days after surgery
Maximal tolerable dose (MTD), defined as a dose level where 2 or more subjects among 6 subjects suffering DLT. If the experiment reached the set maximum dose without any DLT occurring, the maximum dose was defined as MTD.
次要结局
- Adverse events (AE)(7 days after surgery)
- Server adverse events (SAE)(7 days after surgery)
研究者
Shicheng Su
Director of Shuhua Breast Cancer Research Center of Sun Yat- sen Memorial Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University