CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
153 Sm-EDTMP +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00429507
NCT00429507Phase 2Completed
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Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases

M.D. Anderson Cancer Center·interventional·Posted Jan 31, 2007·Updated Nov 24, 2015

In Brief

A Phase 2 clinical trial evaluating 153 Sm-EDTMP, Questionnaire, and 1 other intervention for Breast Cancer and Bone Metastases. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Primary objectives: \- 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: * 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Bone Metastases
CountriesUnited States
CollaboratorsCytogen Corporation

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2007
Enrollment StartMar 1, 2007
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 19.4 years ago

Interventions

153 Sm-EDTMPdrug

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.

Questionnairebehavioral

Questionnaires taking about 15 minutes to complete.

Stem Cell Transplantprocedure

Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.