Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time to Progression
研究概览
简要总结
Primary objectives:
- To determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).
Secondary objectives:
- To determine the overall survival at one year.
- To determine the efficacy of 153Sm-EDTMP at 6 months.
- To assess pain in subjects treated with 153Sm-EDTMP.
- To determine the safety of 153Sm-EDTMP.
详细描述
153 Sm-EDTMP is designed to provide radiation to the bone and bone marrow. The radiation may kill cancer cells.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a breast exam, mammogram, and computed tomography (CT) scan. You will have a bone marrow aspirate/biopsy. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow/bone is withdrawn through a large needle. Blood (about 2 teaspoons) will be drawn to check the status of the disease. You will have x-rays, a bone scan, a positron emissions tomography (PET) scan, and a bone density test. Blood (about 2 teaspoons) will be drawn to check for HIV (the virus that causes AIDS), CMV (cytomegalovirus), Hepatitis B, and Hepatitis C (viruses that can infect the liver). You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have an echocardiogram or multiple-gated acquisition scan (MUGA). An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size. You will have a lung function test to make sure your heart and lungs are healthy. You will complete a questionnaire about the pain you are experiencing. The questionnaire will take about 15 minutes to complete. Women who are able to have children must have a negative blood (about 2 teaspoons) pregnancy test.
If you are found to be eligible to take part in this study, on Day 1 you will receive a tracer dose. A tracer dose is a small amount of the study drug used to measure how the study drug is affecting the body. Your weight will be measured. Before the tracer dose is injected, you will be given fluids through a needle in your veins starting from 2 hours before the tracer dose up to 6 hours afterwards. You will receive a small amount of 153 Sm-EDTMP, called a tracer dose, through a needle in your vein.
After the tracer dose, you will have pictures taken of your body with a gamma camera 3 times that day. These photographs will be taken immediately after the dose is injected, and then 2-3 hours and 4-6 hours later. You will need to lie flat for these imaging sessions for about 10-30 minutes each time.
On Day 2, you will have 1 picture taken of your body with the gamma camera.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IV breast cancer metastatic to bone and/or bone marrow only.
- •Age between 18 and 65 years.
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1
- •Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.
- •Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.
- •White blood cell count (WBC) >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.
- •Adequate pulmonary function defined as forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for hemoglobin) >/= 50% of predicted.
- •Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.
- •Serum total bilirubin < 2x upper limit of normal (ULN), and ALT/serum glutamate pyruvate transaminase (SGPT) < 3x ULN
- •Creatinine clearance of >/= 75 mL/min for subjects up to 50 years of age, and adjusted for age by a 10% decrease per decade for subjects of more than 50 years of age.
- •Ability to understand the study and provide informed consent.
排除标准
- •Any metastatic disease or history of metastatic disease other than skeletal metastases
- •Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.
- •Previous strontium-89 or samarium-153 treatment for any skeletal involvement.
- •Cumulative external beam radiation to > 20% of marrow volume or > 40 Gy to any single region of the spinal cord.
- •Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.
- •Life expectancy severely limited by concomitant illness (less than 6 months).
- •Prior nephrectomy.
- •History of hemorrhagic cystitis obstructive uropathy or hydronephrosis.
- •Uncontrolled arrhythmia or symptomatic cardiac disease.
- •Current gross hematuria in urinalysis (UA) in the absence of vaginal bleeding.
- •Evidence of HIV-seropositivity.
- •Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.
- •Use of any investigational agent within 30 days preceding enrollment.
- •Pregnant or lactating women.
- •Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •Myelodysplastic syndrome.
- •Subject weight of more than 125 kg.
研究组 & 干预措施
Samarium 153-EDTMP + Stem Cell Transplant
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.
干预措施: 153 Sm-EDTMP (Drug)
Samarium 153-EDTMP + Stem Cell Transplant
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.
干预措施: Questionnaire (Behavioral)
Samarium 153-EDTMP + Stem Cell Transplant
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Time to Progression
时间窗: 7.5 Years, Study period was March 2007 to November 2014.
Time to progression is measured as the time from study entry to the development of disease progression.
次要结局
未报告次要终点