Protocol Number: 00-C-0119

Title:

Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer

Number:

00-C-0119

Summary:

This study will examine the safety and effectiveness of allogeneic (donor) bone marrow transplant in treating metastatic breast cancer (breast cancer that has spread to other places in the body, such as the lymph nodes, lungs, liver, or bones.

Patients with metastatic breast cancer age 18 to 75 will be tested for matching with a donor (family member). Both donor and patient will have a medical history, physical examination and blood tests to determine eligibility for the study.

Patients enrolled in the study will have further tests, including CT and MRI scans, bone marrow aspiration, and possibly a tumor needle biopsy before beginning treatment. A central venous catheter (a flexible plastic tube) inserted into a vein will remain in place for the treatment period and will be used to deliver chemotherapy and medications, infuse donor stem cells and white blood cells, transfuse red blood cells or platelets.

Both patient and donor will receive injections of a hormone called G-CSF for 5 to 7 days before the each donate stem cells. G-CSF increases the number of stem cells released from the marrow into the blood, increasing the amount of cells that can be collected.

Patients will receive the drugs fludarabine and cyclophosphamide for 4 days to shrink or stabilize the growth of the breast tumor and to weaken the immune system so that it does not reject and destroy the donated stem cells. Depending on the response of both the tumor and the immune system, the transplant may follow the one dose, or a second dose may be given after a rest period. Additional G-CSF will be given after chemotherapy to increase the white cell count, thereby reducing the risk of infection.

The initial chemotherapy will be followed by 4 consecutive days of "conditioning chemotherapy" of higher doses of fludarabine and cyclophosphamide, beginning 6 days before the transplant. Cyclosporine will be given both before and after the stem cells are infused through the central line to prevent the patient's immune system from rejecting the donated cells and to prevent the donated immune cells from attacking the patient's tissues. The drug will be reduced over several weeks in patients whose tissues are not being damaged by the donor cells.

After discharge from the hospital, patients will continue to take antifungal, antiviral and antibiotic medicines at home. They may receive one or more "booster" infusions of donated white cells at set times to enhance the tumor-killing effect.

Patients will be followed twice weekly for the first 100 days after the transplant with a history, physical examination, and blood tests. After that, visits will be scheduled every 3 months, then every 6 months, and then yearly during the minimum 5 years of follow-up. CT scans will be done every month for the first 6 months.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Chimerism

Cyclosporine

Donor Lymphocyte Infusion

Recruitment Keywords:

Breast Cancer

Metastatic Breast Cancer

Conditions:

Breast Cancer

Breast Neoplasm

Investigational Drug(s):

Cyclophosphamide; Fludarabine; Cyclosporine; Mesna, G-CSF; MABs

3A1

95-5-49

96-6-42

Investigational Device(s):

Baxter Isolex 300i Stem Cell Collection System

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Breast cancer in the medial half Results of 1978 National Survey of the American College of Surgeons

Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-26

Phase II study of weekly intravenous trastuzumab (Herceptin) in patients with HER2/ neu-overexpressing metastatic breast cancer

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004