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
  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
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: 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 July 26, 2014