Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
Other: Autologous Stem Cell Infusion
Radiation: External Beam Radiotherapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma|
- To assess progression free survival of high-risk osteogenic sarcoma to high-dose Samarium-153 EDTMP and external beam radiotherapy [ Time Frame: 6 months after completion of study ] [ Designated as safety issue: No ]6-month progression free survival is the primary endpoint
- Describe the short and long-term side effects of combined infusional Samarium-153 EDTMP and external beam radiotherapy [ Time Frame: Up to 48 months ] [ Designated as safety issue: Yes ]Short and long-term side effects will be measured by reviewing blood work results and constitutional side effects as voiced by patient participants.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: SmEDTMP/Autologous Stem Cell Infusion/RT
Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
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 planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg. After the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the external beam portion of the treatment plan, as necessary. Autologous stem cell infusion is administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.
Other Names:Other: Autologous Stem Cell Infusion
Approximately 14 days after administration of "treatment" dose of Samarium, patients will receive Autologous Stem Cell Infusion.
Other Name: Stem CellsRadiation: 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.
Other Name: Radiation
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 administration) Auto-Stem cell infusion
DAY 40 (approximately two weeks after stem cell rescue) Initiate external beam radiation therapy upon count recovery
One month following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886105
|Contact: Susan Markus, RN, BSN, MS||410 955 firstname.lastname@example.org|
|Contact: David Loeb, MD, PhD||410 502 email@example.com|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator: David Loeb, MD, PhD|
|Principal Investigator:||David Loeb, MD, PhD||Johns Hopkins University|