A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
Osteosarcoma, Bone Metastases
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring dosimetry, radiopharmaceutical, radiotherapy, Maximally tolerated dose, MTD, tumor, myelosuppression
Eligibility Criteria
Inclusion Criteria:
- 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).
- Measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan.
- Adequate renal function, defined as a measured creatinine clearance >70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR).
- Adequate hematologic function, defined as a platelet count > 50,000 cells/mm3 and an absolute neutrophil count (ANC) > 500 cells/mm3
- 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 must have previously received effective treatment for their underlying disease and have no potentially curative options available.
Exclusion Criteria:
- Subject has received prior radiotherapy to all known areas of current active disease or has a known contraindication to receiving radiotherapy.
- Subject is pregnant or breastfeeding.
- Patient is sexually active and does not agree to use accepted, effective forms of contraception.
Sites / Locations
- Montefiore Medical Center-Children's Hospital
Arms of the Study
Arm 1
Experimental
Dose Escalation Arm
Dose Levels 1-3 will consist of treatment with radiopharmaceutical (153Sm-DOTMP) alone. If the maximally tolerated dose (MTD) has not been reached at Level 3, external beam radiotherapy will be added to each of Levels 4-6. Participants enrolled on Dose Levels 4-6 will be treated with external beam radiotherapy to all radiographically evident sites of disease. If an MTD has not been determined at Level 6, the study will end and Dose Level 6 will be declared the Recommended Phase 2 Dose. Participants will be given prophylactic / supportive treatment protocols including Calcium Carbonate, mozobil, and neupogen injectable product.