Phase II Study of Purging of Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products
研究概览
简要总结
The goal of this clinical research study is to learn the relationship of high-dose chemotherapy (HDCT) and circulating tumor cells (CTCs) in controlling metastatic breast cancer. The study also will investigate the role of CTCs in breast cancer.
详细描述
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Carboplatin and thiotepa are designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die. Mesna is designed to prevent toxicities from cyclophosphamide. Granulocyte colony-stimulating factor (G-CSF or GCSF) is designed to help your white blood count recover after transplant.
If you are found to be eligible to take part in this study, you will be given G-CSF twice a day through a needle under the skin (subcutaneous injection), on Days 1-5. On Day 5, stem cell collection will begin. You will have a catheter placed into a vein in your chest. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your physician will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
If further shrinkage of tumor is needed, the doctor may use chemotherapy combined with G-CSF described above. Your doctor will explain this procedure to you in more detail, and you will be asked to sign a separate consent form for this procedure.
Blood will be removed from your body through the catheter and passed through a machine that separates the stem cells from the other cells. The stem cells will be frozen for storage, and the blood will be returned to your body. This 3-hour process is called apheresis. The process will be done once a day for 1-6 days until enough stem cells are collected. Blood ( about 4 teaspoons) will be collected at the first Apheresis to have as a comparison sample to check for any breast cancer leftover in the blood.
The collected blood cells will go through a filter to select out the blood stem cells and the CTCs will be left behind.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 55 years old
- •Metastatic breast carcinoma.
- •Histological confirmation of invasive breast carcinoma
- •Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.
- •Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR).
- •Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy.
- •Zubrod performance status 0 or
- •Patients must have adequate hematological parameters (White Blood Count/WBC >= 3,000/mm3; platelet count >= 100,000/mm3)
- •Adequate renal function (serum creatinine <= 1.5mg/dl)
- •Adequate liver function (total bilirubin, serum glutamate pyruvate transaminase (SGPT) <= 2 times normal).
- •Adequate cardiac function (Left ventricular ejection fraction (LVEF)>= 50%).
- •Adequate pulmonary function (Carbon Monoxide Diffusing Capacity (DLCO)>= 50% of predicted value).
- •Females of childbearing (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent) potential must use adequate contraception.
- •Patients must sign an informed consent.
排除标准
- •Prior HDCT with Autologous hematopoietic stem cell transplantation (AHST) in adjuvant setting.
- •History or presence of brain/leptomeningeal metastasis.
- •History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.
- •Presence of other severe medical illnesses or conditions. Severe heart disease, (myocardial ischemia, myocardial infarction, etc.) Pulmonary disease (COPD, asthma,etc). Renal failure and hepatic failure.
- •Clinically significant active infections (patient requiring IV antibiotics, uncontrolled infections, or hospitalized due to infections).
- •HIV infection.
- •Pregnant or lactating women.
- •Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
研究组 & 干预措施
High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
干预措施: Carboplatin (Drug)
High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
干预措施: Cyclophosphamide (Drug)
High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
干预措施: Thiotepa (Drug)
High-dose chemotherapy
Carboplatin + Cyclophosphamide + Thiotepa
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products
时间窗: Baseline to 1 month post AHST
Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.
次要结局
- Median Progression Free Survival (PFS)(Overall study (baseline to disease progression))