CD34 Selection of the Peripheral Blood Stem Cell Graft for Autologous Transplant

February 26, 2010 updated by: Stanford University

Selection of CD34+THY-1 Positive Cells From Peripheral Blood Cells Procured for Autologous Hematopoietic Support Following High Dose Treatment With BCNU, Cyclophosphamide & Cisplatin for Stage IV Breast Cancer & Limited Prior Treatment

Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+ hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Selection of CD34+THY-1 Positive Cells From Peripheral Blood Cells Procured for Autologous Hematopoietic Support Following High Dose Treatment with BCNU, Cyclophosphamide & Cisplatin for Stage IV Breast Cancer & Limited Prior Treatment

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Phase 2
  • Phase 1

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
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- stage IV breast cancer

  • primary breast cancer does not express CD34+
  • adequate organ function
  • no evidence of active infection Exclusion Criteria:- chemotherapy within 4 weeks
  • CNS disease

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feasibility and safety

Secondary Outcome Measures

Outcome Measure
efficiency of mobilization
tumor contamination

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Ginna Laport, Stanford University

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

September 1, 1996

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 26, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMT86
  • NCT00186680

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.

Subscribe