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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
Sponsor:
Collaborator:
Cytogen Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Bone Metastases
Interventions Drug: 153 Sm-EDTMP
Behavioral: Questionnaire
Procedure: Stem Cell Transplant
Enrollment 12
Recruitment Details Recruitment period: March 7, 2007 to February 4, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Samarium 153-EDTMP + Stem Cell Transplant
Hide Arm/Group Description Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Samarium 153-EDTMP + Stem Cell Transplant
Hide Arm/Group Description Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
52
(36 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Time to Progression
Hide Description Time to progression is measured as the time from study entry to the development of disease progression.
Time Frame 7.5 Years, Study period was March 2007 to November 2014.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Samarium 153-EDTMP + Stem Cell Transplant
Hide Arm/Group Description:
Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Days
317
(105 to 1339)
Time Frame Adverse event collection from initiation of study drug administration through Day 27 post-transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Samarium 153-EDTMP + Stem Cell Transplant
Hide Arm/Group Description Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
All-Cause Mortality
Samarium 153-EDTMP + Stem Cell Transplant
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Samarium 153-EDTMP + Stem Cell Transplant
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Samarium 153-EDTMP + Stem Cell Transplant
Affected / at Risk (%)
Total   12/12 (100.00%) 
Gastrointestinal disorders   
nausea  2  12/12 (100.00%) 
stomatitis  1  12/12 (100.00%) 
Musculoskeletal and connective tissue disorders   
bone pain  1  12/12 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, MedDRA (10.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nato Ueno, MD, PhD/Professor, Breast Medical Oncology
Organization: University of Texas (UT) MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429507     History of Changes
Other Study ID Numbers: 2006-0349
NCI-2010-00573 ( Registry Identifier: NCI CTRP )
First Submitted: January 29, 2007
First Posted: January 31, 2007
Results First Submitted: October 22, 2015
Results First Posted: November 24, 2015
Last Update Posted: November 24, 2015