Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 19, 2014