A Phase II Trial for Patients With Inflammatory (Stage IIIB) and Responsive Metastatic Stage IV Breast Cancer Using Busulfan, Melphalan and Thiotepa Followed by Autologous or Syngeneic PBSC Rescue and 12 Weeks of Post-Engraftment Immunotherapy With Low-Dose IL-2 and GM-CSF
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.
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.
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
*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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium||Seattle, Washington 98109|