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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Cytogen Corporation
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00429507

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Bone Metastases	Drug: 153 Sm-EDTMP Behavioral: Questionnaire Procedure: Stem Cell Transplant	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Samarium Sm 153 lexidronam pentasodium Quadramet

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To see if treatment with radiation from 153 Sm-EDTMP and a stem cell transplant will control breast cancer that has spread to the bone. [ Time Frame: 10 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Samarium 153-EDTMP + Stem Cell Transplant	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-EDTMP Behavioral: Questionnaire Questionnaires taking about 15 minutes to complete. Other Name: Survey Procedure: Stem Cell Transplant Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Other Names: SCT Autologous Peripheral Blood Stem Cell Transplantation PBSCT

Arms

Assigned Interventions

Experimental: Samarium 153-EDTMP + Stem Cell Transplant

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-EDTMP

Behavioral: Questionnaire

Questionnaires taking about 15 minutes to complete.

Other Name: Survey

Procedure: Stem Cell Transplant

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

Other Names:

SCT
Autologous Peripheral Blood Stem Cell Transplantation
PBSCT

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage IV breast cancer metastatic to bone and/or bone marrow only.
Age between 18 and 65 years.
ECOG performance score of 0, 1
Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.
Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.
WBC >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.
Adequate pulmonary function defined as FEV1, FVC and DLCO (corrected for hemoglobin) >/= 50% of predicted.
Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.
Serum total bilirubin < 2x ULN, and ALT/SGPT < 3x ULN
Creatinine clearance of >/= 75 mL/min for subjects up to 50 years of age, and adjusted for age by a 10% decrease per decade for subjects of more than 50 years of age.
Ability to understand the study and provide informed consent.

Exclusion Criteria:

Any metastatic disease or history of metastatic disease other than skeletal metastases
Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.
Previous strontium-89 or samarium-153 treatment for any skeletal involvement.
Cumulative external beam radiation to > 20% of marrow volume or > 40 Gy to any single region of the spinal cord.
Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.
Life expectancy severely limited by concomitant illness (less than 6 months).
Prior nephrectomy.
History of hemorrhagic cystitis obstructive uropathy or hydronephrosis.
Uncontrolled arrhythmia or symptomatic cardiac disease.
Current gross hematuria in UA in the absence of vaginal bleeding.
Evidence of HIV-seropositivity.
Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.
Use of any investigational agent within 30 days preceding enrollment.
Pregnant or lactating women.
Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Myelodysplastic syndrome.
Subject weight of more than 125 kg.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429507

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Cytogen Corporation

Investigators

Principal Investigator:

Naoto Ueno, MD, PhD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00429507 History of Changes
Other Study ID Numbers:	2006-0349
Study First Received:	January 29, 2007
Last Updated:	October 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer
Blood Stem Cell
Bone Metastases
Radiation Therapy
Gamma Camera
Sm-EDTMP

Samarium 153-EDTMP
Stem Cell Transplant
Autologous Peripheral Blood Stem Cell Transplantation
PBSCT
Questionnaire

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases

Musculoskeletal Diseases
Hematologic Diseases
Samarium ethylenediaminetetramethylenephosphonate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012