Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung
Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung
RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the
 immune system in different ways and stop tumor cells from growing.

 PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in
 treating a patient who has undergone a donor stem cell transplant for breast cancer that has
 spread to the lung.
OBJECTIVES:

 Primary

 -  Determine the antitumor response in a patient with persistent metastatic breast cancer
 after prior allogeneic hematopoietic stem cell transplantation (SCT) treated with
 tumor-derived, ex vivo expanded and costimulated T-lymphocytes.

 Secondary

 -  Evaluate the immune function of tumor-derived T-lymphocytes and the biology of residual
 tumor cells present after allogeneic hematopoietic SCT.

 OUTLINE: This is a pilot study.

 The patient undergoes surgical resection of the accessible lesions from which T cells are
 isolated, costimulated, and expanded ex vivo to produce the tumor-derived T-lymphocytes
 (TDTL). Beginning at least 2 weeks after surgery, the patient receives TDTL IV every 4 weeks
 for up to 5 doses in the presence of disease progression (DP) AND in the absence of ≥ grade 2
 graft-versus-host disease. The patient is assessed 4 weeks after every dose.

 In case of stable disease, partial response, or complete response, the patient is followed
 without intervention until DP.

 In case of DP after dose 1 or 2 of the TDTL, the patient receives dose 2 or 3 of the TDTL. In
 case of DP after dose 3 of the TDTL, the patient receives low-dose interleukin-2
 subcutaneously (SC) daily for 3 days and dose 4 of the TDTL. In case of DP after dose 4 of
 the TDTL, the patient receives 1 course of chemoimmunotherapy for cytoreduction and
 immunomodulation comprising paclitaxel IV over 3 hours once and trastuzumab (Herceptin®) IV
 over 30-90 minutes once weekly for 3 weeks (the patient may receive gemcitabine
 hydrochloride, vinorelbine ditartrate, docetaxel, or capecitabine in combination with
 trastuzumab [Herceptin®] as chemoimmunotherapy at the discretion of the principal
 investigator); interleukin-2 SC daily for 3 days; and dose 5 of the TDTL. In case of DP after
 dose 5 of the TDTL, the patient may receive cytotoxic chemotherapy and/or FDA-approved
 biologic therapy and/or immunotherapy with donor lymphocyte infusions from the same donor
 used for the prior allogeneic stem cell transplantation.

 The patient may undergo core biopsy of the left mediastinal nodule in case of tumor
 regression of the indexing lesion at anytime OR after receiving dose 5 of the TDTL.

 After completion of study treatment, the patient is followed periodically for 5 years.

 PROJECTED ACCRUAL: One patient will be accrued for this study.
DISEASE CHARACTERISTICS:

 -  Diagnosis of stage IIB HER2/neu-expressing breast cancer 6½ years ago

 -  Received a T-cell-depleted allogeneic stem cell transplantation (SCT) from a 6/6
 HLA-matched sibling donor for refractory metastatic breast cancer

 -  Developed pulmonary metastases during adjuvant chemotherapy following modified radical
 mastectomy

 -  Pulmonary metastases progressed after prior allogeneic SCT

 -  Responded in an objective and measurable manner to prior allogeneic lymphocyte
 infusion, post-transplantation chemotherapy, and trastuzumab (Herceptin®)

 -  Disease limited to the thoracic cavity

 -  Operable tumor with at least 1 cm of surgically accessible lesion

 -  Preoperative risk assessment indicating ≤ 5% risk of mortality and < 15% risk of
 significant morbidity for pulmonary metastasectomy

 -  Enrolled on protocol CC# 00-C-0119

 -  Hormone receptor status not specified

 PATIENT CHARACTERISTICS:

 -  Female

 -  Menopausal status not specified

 -  ECOG performance status 0-2

 -  Life expectancy > 6 months

 -  Negative pregnancy test

 -  Adequate pulmonary reserve

 -  Prior graft-versus-host disease (GVHD) ≤ grade 1

 -  No concurrent GVHD

 -  No active infection nonresponsive to antimicrobial therapy

 -  No active psychiatric disorder that would preclude study compliance

 PRIOR CONCURRENT THERAPY:

 -  See Disease Characteristics

 -  At least 4 weeks since prior systemic immunosuppressive therapy

 -  At least 2 weeks since prior cytotoxic therapy and immunotherapy (e.g. trastuzumab
 [Herceptin®])

 -  No concurrent immunosuppressive therapy