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

Phase 2

Terminated

Conditions: Metastatic Osteosarcoma

Interventions: Drug: Sm-EDTMP
Other: Autologous Stem Cell Infusion
Radiation: External Beam Radiotherapy

Registration Number: NCT01886105

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SmEDTMP/Autologous Stem Cell Infusion/RT	Sm-EDTMP	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
SmEDTMP/Autologous Stem Cell Infusion/RT	Autologous Stem Cell Infusion	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
SmEDTMP/Autologous Stem Cell Infusion/RT	External Beam Radiotherapy	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity	Up to 48 months	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.