Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Department of Hematology Oncology
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584428
First received: December 20, 2007
Last updated: December 31, 2007
Last verified: December 2007
History of Changes

December 20, 2007
December 31, 2007
June 1992
March 2002   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584428 on ClinicalTrials.gov Archive Site
No secondary outcomes [ Time Frame: Undetermined ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer
High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer

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.

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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
Procedure: High-Dose Chemo with Autologous BMT
Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70
Experimental: 1
Intervention: Procedure: High-Dose Chemo with Autologous BMT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
March 2002
March 2002   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584428
OU 9206, OU 9206
No
George Selby, University of Oklahoma Health Sciences Center
University of Oklahoma
Department of Hematology Oncology
Principal Investigator: George Selby, MD University of Oklahoma
University of Oklahoma
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP