drugset / Trial / NCT00020176
Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
Open-labelTreatment
Summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer.
Timeline
- Start
- 2000-06
- Primary completion
- —
- Completion
- 2007-08
Publications
- Background Bishop MR. Nonmyeloablative allogeneic hematopoietic stem cell transplantation for metastatic breast cancer. Clin Breast Cancer. 2003 Apr;4(1):39-45. doi: 10.3816/cbc.2003.n.010.
- Results Bishop MR, Fowler DH, Marchigiani D, Castro K, Kasten-Sportes C, Steinberg SM, Gea-Banacloche JC, Dean R, Chow CK, Carter C, Read EJ, Leitman S, Gress R. Allogeneic lymphocytes induce tumor regression of advanced metastatic breast cancer. J Clin Oncol. 2004 Oct 1;22(19):3886-92. doi: 10.1200/JCO.2004.01.127. Epub 2004 Aug 16.
- Results Bishop MR, Steinberg SM, Gress RE, Hardy NM, Marchigiani D, Kasten-Sportes C, Dean R, Pavletic SZ, Gea-Banacloche J, Castro K, Hakim F, Krumlauf M, Read EJ, Carter C, Leitman SF, Fowler DH. Targeted pretransplant host lymphocyte depletion prior to T-cell depleted reduced-intensity allogeneic stem cell transplantation. Br J Haematol. 2004 Sep;126(6):837-43. doi: 10.1111/j.1365-2141.2004.05133.x.
- Results Bishop MR, Kasten-Sportes C, Dean R, et al.: Preemptive DLI after T cell-depleted reduced-intensity allogeneic HSCT for metastatic breast cancer: effect on engraftment, GVHD, and anti-tumor response. [Abstract] Blood 102 (11): A- 5567, 2003.
- Results Bishop MR, Marchigiani D, Grasmeder S, et al.: Demonstration of clinical responses to adoptive cellular therapy using allogeneic T cells in metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-657, 2003.
- Results Bishop MR, Marchigiani D, Odom J, et al.: Contribution of T cells to engraftment: a comparison of T cell depleted vs. T cell replete allografts after reduced-intensity conditioning. [Abstract] Blood 102 (11): A-2447, 2003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | therapeutic allogeneic lymphocytes | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cyclosporine | Peptide | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |