deltatrials
Completed PHASE2 NCT00003199

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

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

Sponsor: Fred Hutchinson Cancer Center

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
Interventions aldesleukin busulfan melphalan peripheral blood stem cell transplantation radiation therapy sargramostim tamoxifen citrate thiotepa
Updated 7 times since 2017 Last updated: Jun 16, 2017 Started: Nov 30, 1997 Primary completion: Dec 31, 2009 Completion: Dec 31, 2009

A PHASE2 clinical study on Estrogen Receptor-negative Breast Cancer and Estrogen Receptor-positive Breast Cancer, this trial is completed. The trial is conducted by Fred Hutchinson Cancer Center and has accumulated 7 data snapshots since 1997. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Change History

7 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. May 2022 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — May 2022 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 2 earlier versions

  1. Jul 2017 — Jun 2018 [monthly]

    Completed PHASE2

  2. Jan 2017 — Jul 2017 [monthly]

    Completed PHASE2

    First recorded

Nov 1997

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fred Hutchinson Cancer Center
  • National Cancer Institute (NCI)
Data source: Fred Hutchinson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

  • • Seattle, United States