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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metastatic Osteosarcoma

Intervention / Treatment
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* Drug: Sm-EDTMP
* Other: Autologous Stem Cell Infusion
* Radiation: External Beam Radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmEDTMP/Autologous Stem Cell Infusion/RT<br>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 | Drug: Sm-EDTMP<br>* 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.<br>* Other names: 153Sm-EDTMP;Other: Autologous Stem Cell Infusion<br>* Administered 14 days after Treatment infusion of Samarium-153 EDTMP.<br>* Other names: Stem Cells;Radiation: External Beam Radiotherapy<br>* 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.<br>* Other names: Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Treated Participants With 6-month Progression Free Survival | Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months. | 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity | Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up. | Up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteosarcoma, Osteogenic Sarcoma, Sarcoma, Bone Cancer