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

PHASE2TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 19, 2013

Primary Completion Date

December 11, 2015

Study Completion Date

June 11, 2017

Conditions
Metastatic Osteosarcoma
Interventions
DRUG

Sm-EDTMP

"Subjects receive a tracer infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post tracer infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. Tracer activity will be applied to development of the external beam radiation (EBT) planning. Second treatment infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg."

OTHER

Autologous Stem Cell Infusion

"Administered 14 days after Treatment infusion of Samarium-153 EDTMP."

RADIATION

External Beam Radiotherapy

"The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.~After the treatment infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary."

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER