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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014