Clinical trial · Interventional
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
NCT01886105CI-TRIAL-00041337terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual and loss of funding
Summary
Brief summary (as posted)
The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.
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 |
|---|---|---|---|
| Metastatic Osteosarcoma | Osteosarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Stem Cell Infusion | Other | — | UNRESOLVED |
| External Beam Radiotherapy | Radiation | — | UNRESOLVED |
| Sm-EDTMP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SmEDTMP/Autologous Stem Cell Infusion/RT
- description
- DAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs DAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours DAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion DAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery 1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET
- interventionNames
- Drug: Sm-EDTMP
- Other: Autologous Stem Cell Infusion
- Radiation: External Beam Radiotherapy
Primary outcomes (1)
- measure
- Percentage of Treated Participants With 6-month Progression Free Survival
- timeFrame
- 6 months post-intervention
- description
- Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be between 13 and 65 years of age, inclusive * Must have unresectable primary tumor or metastases * Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not all lesions must be positive on bone scan. * Creatinine clearance \>70ml/min/1.73m2 * ANC \>500/mm3 * Platelets \>50,000/mm3 * Life expectancy \> 8 weeks * Karnofsky performance status \>50% * Stem cell product collected prior to the infusion of Samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry. Exclusion Criteria: * Patient may not be pregnant or breastfeeding. * Patients who have received prior radiotherapy to all areas of current active disease are not eligible.
References
Publications (26)
- BACKGROUNDFRANCIS KC, PHILLIPS R, NICKSON JJ, WOODARD HQ, HIGINBOTHAM NL, COLEY BL. Massive preoperative irradiation in the treatment of osteogenic sarcoma in children; a preliminary report. Am J Roentgenol Radium Ther Nucl Med. 1954 Nov;72(5):813-8. No abstract available. PMID 13207496
- BACKGROUNDJenkin RD, Allt WE, Fitzpatrick PJ. Osteosarcoma. An assessment of management with particular reference to primary irradiation and selective delayed amputation. Cancer. 1972 Aug;30(2):393-400. doi: 10.1002/1097-0142(197208)30:23.0.co;2-2. No abstract available. PMID 4506001
- BACKGROUNDKang CH, Ferguson-Miller S, Margoliash E. Steady state kinetics and binding of eukaryotic cytochromes c with yeast cytochrome c peroxidase. J Biol Chem. 1977 Feb 10;252(3):919-26. PMID 14138
- BACKGROUNDLEE ES, MACKENZIE DH. OSTEOSARCOMA. A STUDY OF THE VALUE OF PREOPERATIVE MEGAVOLTAGE RADIOTHERAPY. Br J Surg. 1964 Apr;51:252-74. doi: 10.1002/bjs.1800510405. No abstract available. PMID 14138245
- BACKGROUNDSingh A, Holmes RA, Farhangi M, Volkert WA, Williams A, Stringham LM, Ketring AR. Human pharmacokinetics of samarium-153 EDTMP in metastatic cancer. J Nucl Med. 1989 Nov;30(11):1814-8. PMID 2478681
- BACKGROUNDWinderen M, Kjonniksen I, Fodstad O. Pronounced therapeutic effect of samarium 153-ethylenediaminetetramethylene phosphonate in an orthotopic human osteosarcoma tibial tumor model. J Natl Cancer Inst. 1995 Feb 1;87(3):221-2. doi: 10.1093/jnci/87.3.221. No abstract available. PMID 7707409
- BACKGROUNDLattimer JC, Corwin LA Jr, Stapleton J, Volkert WA, Ehrhardt GJ, Ketring AR, Anderson SK, Simon J, Goeckeler WF. Clinical and clinicopathologic response of canine bone tumor patients to treatment with samarium-153-EDTMP. J Nucl Med. 1990 Aug;31(8):1316-25.