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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186680
First received: September 14, 2005
Last updated: February 26, 2010
Last verified: February 2010
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Feasibility and safety [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • efficiency of mobilization [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • tumor contamination [ Time Frame: unknown ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ginna Laport, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186680     History of Changes
Other Study ID Numbers: BMT86, BMT86
Study First Received: September 14, 2005
Last Updated: February 26, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 13, 2013