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

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00186680
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1996-09
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-26
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility and safety

Secondary Outcome Measures

Name	Time	Method
efficiency of mobilization
tumor contamination

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States