Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Department of Hematology Oncology
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584766
First received: December 20, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma


Condition Intervention Phase
Metastatic Breast Cancer
Procedure: High-dose chemotherapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Combination Chemotherapy With Autologous Bone Marrow Rescue for Metastatic Breast Cancer After Intitial Cytoreduction With Standard Agents: A Phase II Study

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Quality of maximal response; time to initial disease progression; and overall survival [ Time Frame: undetermined ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer [ Time Frame: undetermined ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 1987
Study Completion Date: May 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: High-dose chemotherapy
Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast carcinoma at first clinical evidence of metastatic disease
  • must have measurable disease by physical exam, x-ray, or scan
  • Age < or equal to 55
  • performance status 0-2

Exclusion Criteria:

  • can't have had more than one prior chemotherapy regimen
  • can't have had concurrent hormonal therapy
  • no brain metastases
  • no previous pelvic radiation
  • no history of another malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584766

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Department of Hematology Oncology
Investigators
Principal Investigator: George Selby, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: George Selby, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00584766     History of Changes
Other Study ID Numbers: OU 8701, OU 8701
Study First Received: December 20, 2007
Last Updated: December 20, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014