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High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00584428
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

Condition or disease Intervention/treatment
Breast Neoplasms Procedure: High-Dose Chemo with Autologous BMT

Detailed Description:
There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer
Study Start Date : June 1992
Primary Completion Date : March 2002
Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Procedure: High-Dose Chemo with Autologous BMT
Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70

Outcome Measures

Primary Outcome Measures :
  1. Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur. [ Time Frame: Undetermined ]

Secondary Outcome Measures :
  1. No secondary outcomes [ Time Frame: Undetermined ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed diagnosis of breast cancer
  • Age 18-70
  • Breast cancer at first clinical evidence of metastatic disease
  • Must have objectively measurable or evaluable disease or be in complete remission

Exclusion Criteria:

  • Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)
  • CNS involvement
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): NCT00584428

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

Responsible Party: Sharon Ross, Regulatory, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00584428     History of Changes
Other Study ID Numbers: OU 9206
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Sharon Ross, University of Oklahoma:
Breast Cancer
Cancer Treatment
Breast Cancer Treatment

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