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

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ClinicalTrials.gov Identifier: NCT00186680
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: high dose chemo then auto hematopoietic cell transplant Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 99 participants
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
Study Start Date : September 1996
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Feasibility and safety

Secondary Outcome Measures :
  1. efficiency of mobilization
  2. tumor contamination


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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


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

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

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