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Name of the Trial

Phase I Study of T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Th2/Tc2 Cells, Administered After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Patients With Metastatic Breast Cancer (NCI-04-C-0131). See the protocol summary ³.

Principal Investigator

Dr. Michael R. Bishop Principal Investigator

Dr. Michael R. Bishop, NCI Center for Cancer Research.

Why Is This Trial Important?

Women whose breast cancer has recurred after treatment and metastasized (spread) to other parts of the body have few viable treatment options. Conventional chemotherapy can extend these women's lives for only a few months at best.

Allogeneic stem cell transplantation (ASCT) has been used to cure patients with hematologic malignancies (blood and bone-marrow cancers) and may represent an effective alternative treatment for some types of solid tumors, including advanced breast cancers. In ASCT, peripheral blood stem cells and T lymphocytes from a sibling donor are infused into the patient's bloodstream after preparatory chemotherapy. The donor T lymphocytes may recognize the patient's cancer cells as foreign and attack them, leading to a potentially curative graft-versus-malignancy effect.

However, ASCT is accompanied by a significant risk of death and a range of serious complications, the most potentially deadly of which is graft-versus-host disease (GVHD). GVHD results when donor T lymphocytes attack a patient's normal tissues. It develops in the majority of transplant patients and represents a major barrier to the wider application of ASCT.

Recent refinements in ASCT have begun to reduce the incidence of GVHD, making the procedure a more attractive treatment option for patients with advanced solid tumors. In this study, researchers are investigating whether ASCT followed by the infusion of donor Th2/Tc2 cells—a type of T lymphocyte that is able to suppress GVHD—can be safely used to treat patients with metastatic breast cancer.

Who Can Join This Trial?

Researchers will recruit 45 women, ages 18 to 75, with metastatic breast cancer that has recurred after treatment. See the list of eligibility criteria ⁴.

Where Is This Trial Taking Place?

The study is taking place at the NIH Clinical Center in Bethesda, Maryland.

Contact Information

For more information, call the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.

Glossary Terms

A procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor.

An immune response to a person's tumor cells by immune cells present in a donor's transplanted tissue, such as bone marrow or peripheral blood.

An immature cell found circulating in the bloodstream. New blood cells develop from peripheral stem cells.