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Allogeneic Stem Cell Transplantation for Metastatic Breast Cancer
Untitled Document
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.
Principal Investigator
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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.
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.
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