Clinical trial

Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By…

NCT00003199 · Fred Hutchinson Cancer Center, Other · Completed

Key facts

NCT number NCT00003199
Title 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
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
Lead sponsor Fred Hutchinson Cancer Center, Other
Collaborators National Cancer Institute (NCI) NIH
Status Completed
Phase Phase 2
Study type Interventional
Conditions 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
Intervention type Biological, Drug, Procedure, Radiation
Interventions tamoxifen citrate, busulfan, thiotepa, melphalan, aldesleukin, sargramostim, peripheral blood stem cell transplantation, radiation therapy
Enrollment 50
Start date Nov 1, 1997
Primary completion Dec 1, 2009
Completion Dec 1, 2009
First posted Jan 27, 2003
Last update posted Jul 12, 2017
Countries United States

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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