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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186680
First Posted: September 16, 2005
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Stanford University
  Purpose
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.

Condition Intervention Phase
Breast Cancer Procedure: high dose chemo then auto hematopoietic cell transplant Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Feasibility and safety

Secondary Outcome Measures:
  • efficiency of mobilization
  • tumor contamination

Estimated Enrollment: 99
Study Start Date: September 1996
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186680


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ginna Laport Stanford University
  More Information

Responsible Party: Ginna Laport, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186680     History of Changes
Other Study ID Numbers: BMT86
First Submitted: September 14, 2005
First Posted: September 16, 2005
Last Update Posted: March 2, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases