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
|ClinicalTrials.gov Identifier: NCT00003199|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 17, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: tamoxifen citrate Drug: busulfan Drug: thiotepa Drug: melphalan Biological: aldesleukin Biological: sargramostim Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 1997|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
Experimental: Arm I
See Detailed Description.
Drug: tamoxifen citrate
Other Names:Drug: busulfan
Other Names:Drug: thiotepa
Other Names:Drug: melphalan
Other Names:Biological: aldesleukin
Other Names:Biological: sargramostim
Other Names:Procedure: peripheral blood stem cell transplantation
Undergo autologous peripheral blood stem cell infusion
Other Names:Radiation: radiation therapy
May undergo radiotherapy after completion of IL-2/GM-CSF
- Event-free Survival [ Time Frame: 11 years ]Event-free 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.
- Overall Survival [ Time Frame: 11 years ]Overall 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.
- Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF [ Time Frame: 16 Weeks ]IL-2/GM-CSF toxicity assessed using the NCI Toxicity Criteria. Toxicity was defined as any grade 2, 3, 4 or 5 CNS (except grade 0-3 malaise and fatigue) toxicity; any grade 3, 4, or 5 non-CNS or non-hematological toxicity (except grade 0-3 bilirubin); or any grade 4 or 5 hematological toxicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003199
|United States, Washington|
|Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Leona A Holmberg||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|