Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
NCT ID: NCT01886105
Last Updated: 2019-10-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2013-08-19
2017-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SmEDTMP/Autologous Stem Cell Infusion/RT
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
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.
Autologous Stem Cell Infusion
Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.
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.
Interventions
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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.
Autologous Stem Cell Infusion
Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who have received prior radiotherapy to all areas of current active disease are not eligible.
10 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jazz Pharmaceuticals
INDUSTRY
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Brian Ladle, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NA_00075773
Identifier Type: OTHER
Identifier Source: secondary_id
J1322
Identifier Type: -
Identifier Source: org_study_id
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