Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma

Stopped early · Phase 2

Conditions studied: Metastatic Osteosarcoma

In brief

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.

Key facts

Study ID

NCT01886105

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

4

Starts

2013-08-19

Expected to finish

2017-06-11

Last updated by the study team

2019-10-29

Who can join

Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient may not be pregnant or breastfeeding.
• Patients who have received prior radiotherapy to all areas of current active disease are not eligible.

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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