Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer

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.

Sex

All

Minimum age

18 Years

Maximum age

70 Years

DISEASE CHARACTERISTICS:

* Stage IV breast cancer
* Measurable disease
* Progressive disease

  * Increase in disease mass or less than partial response to therapy
  * At least one prior chemotherapy regimen for metastatic disease and progressed

    * Must have received prior therapy with a taxane and an anthracycline
* Estrogen/progesterone receptor-positive patients must have received and progressed on at least one hormonal agent in adjuvant or metastatic setting
* Her2-neu-expressing patients must have received and progressed on trastuzumab (Herceptin®) in adjuvant or metastatic setting
* Prior autologous stem cell transplantation allowed if less than complete response or disease progression in adjuvant or metastatic setting
* Consenting first-degree relative with at least 5 out of 6 HLA-antigen match (may include mismatch at the D locus)
* Hormone receptor status:

  * Estrogen receptor status known
  * Progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

* 18 to 70

Sex:

* Male or female

Menopausal status:

* Not specified

Performance status:

* Karnofsky 80-100%

Life expectancy:

* More than 6 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin ≤ 2 mg/dL
* SGOT \< 4 times upper limit of normal
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative

Renal:

* Creatinine ≤ 1.5 mg/dL
* Creatinine clearance ≥ 50 mL/min

Cardiovascular:

* Left ventricular ejection fraction \> 45%

Pulmonary:

* DLCO ≥ 50% of predicted

Other:

* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics
* Recovered from prior stem cell transplantation

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* See Disease Characteristics
* No concurrent steroids

Radiotherapy:

* Not specified

Surgery:

* Not specified

• BACKGROUNDBishop 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. PMID 12744757
• RESULTBishop 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. PMID 15314059
• RESULTBishop 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. PMID 15352988
• RESULTBishop 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.
• RESULTBishop 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.
• RESULTBishop 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.