Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases

Trial Information

Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases

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a small amount of bone marrow/bone is withdrawn through a large needle.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.