Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
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|ClinicalTrials.gov Identifier: NCT00429507|
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : November 24, 2015
Last Update Posted : November 24, 2015
- To determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).
- To determine the overall survival at one year.
- To determine the efficacy of 153Sm-EDTMP at 6 months.
- To assess pain in subjects treated with 153Sm-EDTMP.
- To determine the safety of 153Sm-EDTMP.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Bone Metastases||Drug: 153 Sm-EDTMP Behavioral: Questionnaire Procedure: Stem Cell Transplant||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: Samarium 153-EDTMP + Stem Cell Transplant
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.
Drug: 153 Sm-EDTMP
Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
Other Name: Samarium 153-EDTMPBehavioral: Questionnaire
Questionnaires taking about 15 minutes to complete.
Other Name: SurveyProcedure: Stem Cell Transplant
Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
- Time to Progression [ Time Frame: 7.5 Years, Study period was March 2007 to November 2014. ]Time to progression is measured as the time from study entry to the development of disease progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429507
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PhD||M.D. Anderson Cancer Center|