Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Intensive Combination Chemotherapy With Autologous Bone Marrow Rescue for Metastatic Breast Cancer After Intitial Cytoreduction With Standard Agents: A Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584766
• Other study ID #: OU 8701
• Secondary ID: OU 8701
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: May 28, 2015
• Start date: October 1987
• Est. completion date: May 2002

Study information

• Verified date: May 2015
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2002
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• breast carcinoma at first clinical evidence of metastatic disease

• must have measurable disease by physical exam, x-ray, or scan

• Age < or equal to 55

• performance status 0-2

Exclusion Criteria:

• can't have had more than one prior chemotherapy regimen

• can't have had concurrent hormonal therapy

• no brain metastases

• no previous pelvic radiation

• no history of another malignancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Procedure:
• High-dose chemotherapy
Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of maximal response; time to initial disease progression; and overall survival		undetermined	No
Secondary	to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer		undetermined	No