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

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Cytogen Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429507
  Purpose

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:

  1. To determine the overall survival at one year.
  2. To determine the efficacy of 153Sm-EDTMP at 6 months.
  3. To assess pain in subjects treated with 153Sm-EDTMP.
  4. 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

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

ChemIDplus related topics:   Samarium Sm 153 lexidronam pentasodium   

U.S. FDA Resources

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

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: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The side effects of the study drug will also be studied. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

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
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.

Show detailed description  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:

  1. Stage IV breast cancer metastatic to bone and/or bone marrow only.
  2. Age between 18 and 65 years.
  3. ECOG performance score of 0, 1
  4. 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.
  5. 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.
  6. Subject must have a minimum of 2x10^6 un-manipulated CD34+ cells/kg cryopreserved and available as a source of stem cells for autologous transplant.
  7. WBC >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.
  8. Adequate pulmonary function defined as FEV1, FVC and DLCO (corrected for hemoglobin) >/= 50% of predicted.
  9. Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.
  10. Serum total bilirubin < 2x ULN, and ALT/SGPT < 3x ULN
  11. 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.
  12. Ability to understand the study and provide informed consent.

Exclusion Criteria:

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

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

Contacts
Contact: Naoto Ueno, MD, PhD     713-792-8754    

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Naoto Ueno, MD, PhD            

Sponsors and Collaborators
M.D. Anderson Cancer Center
Cytogen Corporation

Investigators
Principal Investigator:     Naoto Ueno, MD, PhD     U.T. M.D. Anderson Cancer Center    
  More Information


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

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

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer  
Blood Stem Cell  
Bone Metastases  
Sm-EDTMP
Questionnaire
Survey

Study placed in the following topic categories:
Skin Diseases
Samarium ethylenediaminetetramethylenephosphonate
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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