High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer
This study has been completed.
Sponsor:
University of Oklahoma
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
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Purpose
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 | Intervention |
|---|---|
|
Breast Neoplasms |
Procedure: High-Dose Chemo with Autologous BMT |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- No secondary outcomes [ Time Frame: Undetermined ] [ Designated as safety issue: No ]
| Enrollment: | 61 |
| Study Start Date: | June 1992 |
| Study Completion Date: | March 2002 |
| Primary Completion Date: | March 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584428
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: | NCT00584428 History of Changes |
| Other Study ID Numbers: | OU 9206, OU 9206 |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 31, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Oklahoma:
|
Breast Cancer Cancer Treatment Breast Cancer Treatment |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013