Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
Condition: Breast Cancer; Bone Metastases
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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      small amount of bone marrow/bone is withdrawn through a large needle.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.

      If, based on the photographs taken, doctors find that the drug does not go to your bones as
      expected, you will be removed from the study. If you leave the study at this point, you will
      have return to the clinic 2 times a week for the next 4 weeks. At these visits you will have
      a complete physical exam, and you will be asked about any side effects you may be
      experiencing.

      If enough of the study drug does go to your bones, you will receive a higher dose of 153
      Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.

      Before the therapy dose begins, you will have a physical exam, including measurement of your
      vital signs. Fluids will be given through a needle in your vein beginning 2 hours before the
      therapy dose and continuing up to 6 hours after.

      You will receive the injection of 153 Sm-EDTMP through your central line. The injection will
      take about 15 minutes. Afterwards, your vital signs will be measured. Blood (about 2
      teaspoons) will be drawn for routine tests.

      The therapy dose of 153 Sm-EDTMP is expected to destroy your body's ability to make blood
      cells. To restore your blood-making ability, you will be given back stem cells (blood-forming
      cells) that will have already been taken from your body and stored for this treatment. This
      is called an autologous peripheral blood stem cell transplant. You will receive the stem
      cells given through a needle in your vein 14-21 days after the therapy dose usually as an
      outpatient procedure.

      Family members may not be allowed with you until radiation subsides. This will reduce their
      exposure to radiation. You will be given instructions on how to follow radiation safety
      practices.

      Once the radiation subsides you will be released from the hospital, at least 2 times a week
      you will have a complete physical exam, and you will be asked about any side effects you are
      experiencing. Blood (about 2 teaspoons) will be drawn up to 3 times a week until your stem
      cell transplant. Your vitals signs will also be checked 2 times a week.

      After the transplant, at least 2 times a week for up to two (2) weeks your blood (about 2
      teaspoons) will be drawn for routine tests. You will have a physical exam and your vital
      signs will be checked. You will receive additional care, drugs, or blood transfusions, as
      needed.

      You will return for follow-up visits every 3 months until the end of Year 2 and then every 6
      months in Years 3 and 4. Tests may occur more often if a side effect is noticed. Any side
      effects that you develop will be monitored until it goes away. Some of these exams and tests
      may take place with your home doctor, and these records will need to be sent to the study
      doctor so he/she can review them for careful monitoring.

      In order to check the response of the cancer to the study therapy, you will have chest
      x-rays, CT scans, and bone scans every 3 months for the first 2 years after transplant. These
      will be repeated every 6 months in years 3-4 and once a year after that, as long as your
      cancer does not get worse. If the breast cancer has spread to your bone marrow at the time
      you enter this study, bone marrow biopsies will also be done at these times to see whether
      the cancer is responding. You will also have a PET scan at 6 months after transplant, and
      more often if your physician believes it will be helpful. Mammograms and bone density exams
      will be done once a year.

      Once a year for the 10 years after you leave the study, you will have a study visit or you
      will be contacted by telephone. You will be asked about your general health, hospitalization,
      and cancer treatments.

      This is an investigational study. 153 Sm-EDTMP is FDA-approved and commercially available for
      bone pain control. Up to 40 patients will take part in this study. All will be enrolled at M.
      D. Anderson.
    

Intervention name(s): 153 Sm-EDTMP; Questionnaire; Stem Cell Transplant
Intervention type(s): Drug; Behavioral; Procedure
Intervention description(s): Tracer dose = 30 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.; Questionnaires taking about 15 minutes to complete.; Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
Other intervention name(s): Samarium 153-EDTMP; Survey; SCT; Autologous Peripheral Blood Stem Cell Transplantation; PBSCT
Intervention MeSH terms: Samarium Sm-153 lexidronam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Blood Stem Cell; Bone Metastases; Radiation Therapy; Gamma Camera; Sm-EDTMP; Samarium 153-EDTMP; Stem Cell Transplant; Autologous Peripheral Blood Stem Cell Transplantation; PBSCT; Questionnaire