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Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases

NCT00429507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-11-24

Study results available
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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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Cytogen Corporation

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naoto Ueno, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429507 on ClinicalTrials.gov