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

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ClinicalTrials.gov Identifier: NCT00429507
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : November 24, 2015
Last Update Posted : November 24, 2015
Sponsor:
Collaborator:
Cytogen Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Bone Metastases Drug: 153 Sm-EDTMP Behavioral: Questionnaire Procedure: Stem Cell Transplant Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Samarium 153-EDTMP + Stem Cell Transplant
Samarium 153-EDTMP tracer dose = 30 millicurie (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. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.
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




Primary Outcome Measures :
  1. Time to Progression [ Time Frame: 7.5 Years, Study period was March 2007 to November 2014. ]
    Time to progression is measured as the time from study entry to the development of disease progression.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. Eastern Cooperative Oncology Group (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. White blood cell count (WBC) >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.
  7. Adequate pulmonary function defined as forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for hemoglobin) >/= 50% of predicted.
  8. Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.
  9. Serum total bilirubin < 2x upper limit of normal (ULN), and ALT/serum glutamate pyruvate transaminase (SGPT) < 3x ULN
  10. 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.
  11. 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 urinalysis (UA) in the absence of vaginal bleeding.
  11. Evidence of HIV-seropositivity.
  12. Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.
  13. Use of any investigational agent within 30 days preceding enrollment.
  14. Pregnant or lactating women.
  15. Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  16. Myelodysplastic syndrome.
  17. Subject weight of more than 125 kg.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429507


Locations
United States, Texas
University of Texas 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429507     History of Changes
Other Study ID Numbers: 2006-0349
NCI-2010-00573 ( Registry Identifier: NCI CTRP )
First Posted: January 31, 2007    Key Record Dates
Results First Posted: November 24, 2015
Last Update Posted: November 24, 2015
Last Verified: October 2015

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Samarium Sm-153 lexidronam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs