High Dose Samarium-153 With Peripheral Blood Stem Cell Support in High Risk Osteogenic Sarcoma
- Determine the clinical response in patients with recurrent or refractory, metastatic,
or unresectable osteosarcoma treated with high-dose samarium Sm 153 lexidronam
pentasodium (^153Sm-EDTMP) and autologous peripheral blood stem cell transplantation
followed by external-beam radiotherapy.
- Correlate the amount of radiation delivered to a tumor with low-dose ^153Sm-EDTMP with
that of high-dose ^153Sm-EDTMP in patients treated with this regimen.
- Determine the overall and progression-free survival of patients treated with this
- Determine the toxicity of this regimen in these patients.
- Determine the long-term effects of this regimen in these patients.
- Determine the predictive value of fludeoxyglucose F 18 positron emission tomography
(FDG-PET), diffusion-weighted MRI, and magnetic resonance spectroscopy for evaluation
of treatment response in patients treated with this regimen.
OUTLINE: Patients are stratified according to resectability of the primary tumor (recurrent,
refractory, or very high-risk disease vs unresectable primary tumor).
- Mobilization and collection of autologous peripheral blood stem cells (PBSCs)* :
Patients receive ifosfamide IV daily for 5 days followed by filgrastim (G-CSF)
subcutaneously daily. Patients then undergo leukapheresis for collection of autologous
PBSCs until ≥ 2 x 10^6 CD34-positive cells/kg are collected.
NOTE: *Patients who have undergone PBSC collection before study entry proceed to high-dose
samarium Sm 153 lexidronam pentasodium (153Sm-EDTMP) infusion without mobilization and
collection of autologous PBSCs.
- 153Sm-EDTMP infusion: Patients receive a trace dose of ^153Sm-EDTMP** IV over 1-2
minutes and undergo bone scan 4, 24, and 48-72 hours later. Six weeks later, patients
receive high-dose ^153Sm-EDTMP IV over 1-2 minutes and undergo repeat bone scans 4, 24,
and 48-72 hours later.
NOTE: **Patients may receive the trace dose on protocol JHOC-J0094.
- Autologous peripheral blood stem cell transplantation (PBSCT): Between 12-14 days after
administration of high-dose ^153Sm-EDTMP, patients undergo autologous PBSCT. Beginning
2 days later, patients receive G-CSF IV daily.
- External-beam radiotherapy: Patients then undergo external-beam radiotherapy to the
sites of bulky disease.
- Surgery: Some patients may also undergo surgical resection of residual disease. After
completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1 week after study treatment
David M. Loeb, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|