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Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00584766
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 29, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Procedure: High-dose chemotherapy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 1987
Primary Completion Date : May 2002
Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Quality of maximal response; time to initial disease progression; and overall survival [ Time Frame: undetermined ]

Secondary Outcome Measures :
  1. to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer [ Time Frame: undetermined ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584766


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

Responsible Party: George Selby, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00584766     History of Changes
Other Study ID Numbers: OU 8701
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

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