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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Cytogen Corporation |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00429507 |
Primary Objective:
1. 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).
Secondary Objectives:
Condition | Intervention | Phase |
Breast Cancer Bone Metastases |
Drug: 153 Sm-EDTMP Behavioral: Questionnaire Procedure: Stem Cell Transplant |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Samarium Sm 153 lexidronam pentasodium |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Samarium 153-EDTMP + Stem Cell Transplant
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Drug: 153 Sm-EDTMP
Tracer dose = 30 mCi IV On Day 1. If enough of the study drug goes to your bones, you will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.
Behavioral: Questionnaire
Questionnaires taking about 15 minutes to complete.
Procedure: Stem Cell Transplant
Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Naoto Ueno, MD, PhD | 713-792-8754 |
United States, Texas | |||||
U.T. M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Naoto Ueno, MD, PhD |
M.D. Anderson Cancer Center |
Cytogen Corporation |
Principal Investigator: | Naoto Ueno, MD, PhD | U.T. M.D. Anderson Cancer Center |
UT MD Anderson Cancer Center website 
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Responsible Party: | U.T.M.D. Anderson Cancer Center ( Naoto Ueno, MD, PhD/Associate Professor ) |
Study ID Numbers: | 2006-0349 |
First Received: | January 29, 2007 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00429507 |
Health Authority: | United States: Institutional Review Board |
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