Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung
Condition: Breast Cancer; Metastatic Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): aldesleukin; therapeutic tumor infiltrating lymphocytes; trastuzumab; paclitaxel; conventional surgery
Intervention type(s): Biological; Biological; Biological; Drug; Procedure
Intervention MeSH terms: Aldesleukin; Paclitaxel; Trastuzumab
Primary purpose: Treatment
Keywords: lung metastases; stage IV breast cancer; recurrent breast cancer