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

Completed · Phase 2

Conditions studied: Breast Cancer, Bone Metastases

In brief

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.

Key facts

Study ID

NCT00429507

Run by

M.D. Anderson Cancer Center

People needed

12

Starts

2007-03-01

Expected to finish

2014-11-01

Last updated by the study team

2015-11-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage IV breast cancer metastatic to bone and/or bone marrow only.
• Age between 18 and 65 years.
• Eastern Cooperative Oncology Group (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.
• White blood cell count (WBC) >/= 3.5 x10\^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10\^9/L.
• 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.
• Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.
• Serum total bilirubin < 2x upper limit of normal (ULN), and ALT/serum glutamate pyruvate transaminase (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.

You may not qualify if…

• 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 urinalysis (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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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