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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cytogen Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429507
First received: January 29, 2007
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: 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:

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
Samarium 153-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. 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

  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. WBC >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.
  7. Adequate pulmonary function defined as FEV1, FVC and 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 ULN, and ALT/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 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.
  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 19, 2012
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 May 19, 2013