CycloSam and External Beam Radiotherapy for the Treatment of High Risk Osteosarcoma and Other Solid Tumors Metastatic to Bone

Inclusion Criteria

• Subjects will be between the ages of 15 and 65, inclusive
• Subject must have a histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of osteosarcoma with either an unresectable primary tumor or metastases (including tumors with an intralesional resection)
• Subject must have measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan. Not all lesions must be positive on bone scan
• Adequate renal function, defined as a measured creatinine clearance > 70 ml/min/1.73 m^2 or normal radioisotope glomerular filtration rate (GFR)
• Platelet count > 50,000 cells/mm^3
• Absolute neutrophil count (ANC) > 500 cells/mm^3
• Life expectancy of at least 8 weeks
• Karnofsky performance status > 50%
• Subject must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to Common Terminology Criteria for Adverse Events (CTCAE)4.0 grade 2 or better
• Patients with previously identified cardiac disease will be eligible, as 153Sm-DOTMP is not expected to cause cardiac dysfunction and is only expected to result in very transient hypocalcemia
• A stem cell product collected either by peripheral stem cell mobilization or bone marrow harvest prior to the infusion of CycloSam must be available, prior to trial entry. A minimum of 2 x 10^6 CD34+ cells/kg ideal body weight are required
• The patient and/or the patient’s legally authorized guardian, if the subject is a minor, must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services
• Patients must have previously received effective treatment for their underlying disease and have no potentially curative options available
• The concurrent use of hormonal therapies or bisphosphonates is acceptable, provided the latter do not render target lesions invisible on 99mTc bone scan

Exclusion Criteria

• Patient is pregnant or breastfeeding
• Patient is sexually active and does not agree to use accepted, effective forms of contraception
• Patient has received prior radiotherapy to all known areas of current active disease or has a known contraindication to receiving radiotherapy