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

November 20, 2019 updated by: University of Oklahoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Undetermined

Secondary Outcome Measures

Outcome Measure
Time Frame
No secondary outcomes
Time Frame: Undetermined
Undetermined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Stephenson Cancer Center

Investigators

  • Principal Investigator: George Selby, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1992

Primary Completion (Actual)

March 1, 2002

Study Completion (Actual)

March 1, 2002

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 31, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OU 9206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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