High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

High Dose Chemotherapy With Autologous Bone Marrow Transplantation in the Treatment of Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584428
• Other study ID #: OU 9206
• Secondary ID: OU 9206
• Status: Completed
• Phase: N/A
• Start date: June 1992
• Est. completion date: March 2002

Study information

• Verified date: November 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

Description:

There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of breast cancer

• Age 18-70

• Breast cancer at first clinical evidence of metastatic disease

• Must have objectively measurable or evaluable disease or be in complete remission

Exclusion Criteria:

• Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)

• CNS involvement

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• High-Dose Chemo with Autologous BMT
Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Stephenson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur.		Undetermined
Secondary	No secondary outcomes		Undetermined