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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082953 |
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Allogeneic stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Eliminating the T cells from the donor cells before transplanting them and giving cyclosporine may prevent this from happening. Infusing donor T cells that have been treated in the laboratory may be effective in killing metastatic tumor cells by making an immune response against the person's tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated donor T cells when given after chemotherapy, reduced-intensity transplantation conditioning (chemotherapy given before the transplant in doses that will not destroy all bone marrow cells), and T cell-depleted (T cells removed) donor stem cell transplantation in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood lymphocyte therapy Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Allogeneic Breast Protocol 2: Phase I Trial Of T Cell Exchange With Th2/Tc2 Cells For Allogeneic Stem Cell Transplantation After Reduced Intensity Conditioning For Metastatic Breast Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of Th2/Tc2 cells.
Patients are followed every 2 weeks until approximately day 100 and then at 6, 9, 12, 18 and 24 months.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 2-3 years.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Received at least 1 prior chemotherapy regimen for treatment of distant metastases and achieved less than a complete response
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Michael R. Bishop, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000361744, NCI-04-C-0131 |
Study First Received: | May 14, 2004 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00082953 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer male breast cancer |
Cyclosporine Skin Diseases Clotrimazole Miconazole Tioconazole Breast Neoplasms Cyclophosphamide |
Fludarabine monophosphate Cyclosporins Recurrence Breast Neoplasms, Male Fludarabine Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Antifungal Agents Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |