At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed osteosarcoma with high-risk features: recurrent disease, refractory to conventional therapy, newly diagnosed metastatic disease with ≥4 pulmonary nodules or multiple bone lesions, or unresectable primary tumor
- ✓Measurable disease on technetium Tc 99m diphosphonate bone scan
- ✓Refractory to all standard therapies or highly unlikely to respond to conventional treatment
- ✓Karnofsky performance status 60-100%
- ✕Pregnant or nursing women
- ✕Positive pregnancy test in females of childbearing potential
- ✕Fertile patients who do not agree to use effective contraception
- ✕Prior radiotherapy to the site of currently active disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
High Dose Samarium-153 With Peripheral Blood Stem Cell Support in High Risk Osteogenic Sarcoma
In Brief
A Phase 2 clinical trial evaluating filgrastim, ifosfamide, and 3 other interventions for Sarcoma. Completed, enrolled 11 participants across 1 site.
Detailed Summary
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
Study Details
Timeline
Interventions
Filgrastim will be administered post post chemotherapy until target WBC (white blood cell) count is achieved.
Ifosfamide administered IV.
Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered
Sm-EDTMP (low dose) administered after autologous stem cell collection
Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.