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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186680
• Other study ID #: BMT86
• Secondary ID: BMT86
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 14, 2005
• Last updated: February 26, 2010
• Start date: September 1996
• Est. completion date: June 2005

Study information

• Verified date: February 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• high dose chemo then auto hematopoietic cell transplant

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety		unknown	Yes
Secondary	efficiency of mobilization		unknown	No
Secondary	tumor contamination		unknown	No