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

Johns Hopkins Medicine

Status and phase: Terminated; Phase 2

Conditions: Metastatic Osteosarcoma

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01886105

J1322

NA_00075773 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

SmEDTMP/Autologous Stem Cell Infusion/RT

Experimental group

Description:

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

Treatment:

Radiation: External Beam Radiotherapy

Other: Autologous Stem Cell Infusion

Drug: Sm-EDTMP