Clinical trial · Interventional
Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma
High Dose Samarium-153 With Peripheral Blood Stem Cell Support in High Risk Osteogenic Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| sm-EDTMP (higher dose) | Radiation | — | UNRESOLVED |
| Sm-EDTMP (low dose) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Samarium-153
- description
- Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.
- interventionNames
- Biological: filgrastim
- Drug: ifosfamide
- Procedure: peripheral blood stem cell transplantation
- Radiation: Sm-EDTMP (low dose)
- Radiation: sm-EDTMP (higher dose)
Primary outcomes (1)
- measure
- Tumor Response
- timeFrame
- 1 week after study treatment
- description
- WHO (World Health Organization) tumor measurement criteria used to determine response.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion
* Diagnosis of osteosarcoma
* High-risk disease, meeting 1 of the following criteria:
* Recurrent disease
* Refractory to conventional therapy
* Newly diagnosed metastatic disease with ≥ 4 pulmonary nodules or multiple bone lesions
* Unresectable primary tumor
* Prior intralesional resection allowed
* Measurable disease by technetium Tc 99m diphosphonate bone scan
* Refractory to all standard therapies or highly unlikely to respond to conventional treatment
* Performance status Karnofsky 60-100%
* Life expectancy more than 8 weeks
* Absolute neutrophil count \> 500/mm\^3
* Platelet count \> 50,000/mm\^3
* Creatinine clearance \> 70 mL/min OR \* Radioisotope glomerular filtration rate normal
* Recovered from prior chemotherapy
Exclusion
* Pregnant or nursing
* Positive pregnancy test for females of childbearing potential
* Fertile patients do not agree to use effective contraception
* Prior radiotherapy to the site of currently active disease
* Concurrent enrollment on protocol JHOC-J0094 allowedReferences
Publications (3)
- RESULTSenthamizhchelvan S, Hobbs RF, Song H, Frey EC, Zhang Z, Armour E, Wahl RL, Loeb DM, Sgouros G. Tumor dosimetry and response for 153Sm-ethylenediamine tetramethylene phosphonic acid therapy of high-risk osteosarcoma. J Nucl Med. 2012 Feb;53(2):215-24. doi: 10.2967/jnumed.111.096677. Epub 2012 Jan 17. PMID 22251554
- RESULTLoeb DM, Hobbs RF, Okoli A, Chen AR, Cho S, Srinivasan S, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Tandem dosing of samarium-153 ethylenediamine tetramethylene phosphoric acid with stem cell support for patients with high-risk osteosarcoma. Cancer. 2010 Dec 1;116(23):5470-8. doi: 10.1002/cncr.25518. Epub 2010 Aug 16. PMID 20715156
- RESULTLoeb DM, Garrett-Mayer E, Hobbs RF, Prideaux AR, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Dose-finding study of 153Sm-EDTMP in patients with poor-prognosis osteosarcoma. Cancer. 2009 Jun 1;115(11):2514-22. doi: 10.1002/cncr.24286. PMID 19338063