Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
Condition: Estrogen Receptor-negative Breast Cancer; Estrogen Receptor-positive Breast Cancer; Inflammatory Breast Cancer; Male Breast Cancer; Progesterone Receptor-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Stage IIIB Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms; Breast Neoplasms, Male; Inflammatory Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well giving combination chemotherapy and peripheral blood
      stem cell transplant followed by aldesleukin and sargramostim works in treating patients with
      inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy,
      such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell
      transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.
      This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin
      may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together
      with sargramostim may kill more tumor cells
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the event-free survival and survival of patients treated for inflammatory
      (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose
      immunotherapy with IL2 and GM-CSF.

      SECONDARY OBJECTIVES:

      II. To determine the toxicity of a combination of low-dose IL-2 and GM-CSF in patients
      following HDC with BUMELTT and PBSC support.

      OUTLINE:

      PREPARATIVE REGIMEN: Patients receive busulfan orally (PO) once every 6 hours on days -8, -7,
      and -6; melphalan IV over 30 minutes on days -5 and -4; and thiotepa IV over 2 hours on days
      -3 and -2.

      TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell infusion on day 0.

      POST-TRANSPLANT THERAPY: All patients receive tamoxifen citrate* PO once daily beginning
      prior to aldesleukin (IL-2) and sargramostim (GM-CSF) therapy and continuing for 5 years or
      until relapse (estrogen receptor [ER]- or progesterone receptor [PR]-positive patients) OR
      until completion of IL-2/GM-CSF therapy (ER-negative or PR-negative patients). Eligible
      patients receive IL-2 subcutaneously (SC) daily and GM-CSF SC 3 times weekly for 12 weeks
      beginning 30-100 days after transplantation. Patients may receive radiotherapy after
      completion of IL-2/GM-CSF treatment if no prior radiotherapy was given before
      transplantation.

      *Stage IV patients not receiving IL-2/GM-CSF therapy who received tamoxifen citrate as part
      of adjuvant therapy and subsequently failed, receive oral anastrozole once daily for 5 years
      or until progression instead of tamoxifen.

      [*For postmenopausal patients, the choice and duration of hormonal therapy given in addition
      to or an alternative to tamoxifen therapy will be at the physician's discretion]

      Patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.
    

Intervention name(s): tamoxifen citrate; busulfan; thiotepa; melphalan; aldesleukin; sargramostim; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Biological; Biological; Procedure; Radiation
Intervention description(s): Given orally; Given orally; Given IV; Given IV; Given SC; Given SC; Undergo autologous peripheral blood stem cell infusion; May undergo radiotherapy after completion of IL-2/GM-CSF
Other intervention name(s): Nolvadex; TAM; tamoxifen; TMX; BSF; BU; Misulfan; Mitosan; Myeloleukon; Oncotiotepa; STEPA; TESPA; Tespamin; TSPA; Alkeran; CB-3025; L-PAM; L-phenylalanine mustard; L-Sarcolysin; IL-2; Proleukin; recombinant human interleukin-2; recombinant interleukin-2; GM-CSF; Leukine; Prokine; PBPC transplantation; PBSC transplantation; peripheral blood progenitor cell transplantation; transplantation, peripheral blood stem cell; irradiation; radiotherapy; therapy, radiation
Intervention MeSH terms: Tamoxifen; Aldesleukin; Melphalan; Busulfan; Thiotepa; Interleukin-2; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment