Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases
Condition: Breast Cancer; Bone Metastases
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Intervention: 153 Sm-EDTMP; Questionnaire; Stem Cell Transplant
Intervention description: 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.; Questionnaires taking about 15 minutes to complete.; Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.
Intervention MeSH terms: Samarium Sm-153 lexidronam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: 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

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.
    

Eligibility 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.