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

• Status: Terminated
• Trial end date: 2017-06-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Jazz Pharmaceuticals; National Cancer Institute (NCI)
• Treatments: Samarium ethylenediaminetetramethylenephosphonate; Samarium Sm-153 lexidronam

Criteria

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.