Clinical trial · Interventional
A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
A Dose Finding Study of CycloSam® (153Sm-DOTMP) Combined With External Beam Radiotherapy to Treat High Risk Osteosarcoma and Other Solid Tumors Metastatic to Bone
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study withdrawn before any participants could be enrolled. Issues being able to effectively recruit participants into the study.
Summary
Brief summary (as posted)
This is a dose finding study of a novel radiopharmaceutical agent, 153Sm-DOTMP. It will be studied alone and then in combination with external beam radiotherapy. The study design includes six cohorts, Levels 1-6. The first three cohorts of participants will receive 153Sm-DOTMP alone, and if this is determined to be safe, subsequent cohorts will receive the radiopharmaceutical followed by external beam radiotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 153Sm-DOTMP | Drug | — | UNRESOLVED |
| Calcium Carbonate | Drug | — | UNRESOLVED |
| External beam radiotherapy. | Radiation | — | UNRESOLVED |
| Mozobil | Drug | Plerixafor | ALIAS |
| Neupogen Injectable Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation Arm
- description
- 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.
- interventionNames
- Drug: 153Sm-DOTMP
- Radiation: External beam radiotherapy.
- Drug: Calcium Carbonate
- Drug: Mozobil
- Drug: Neupogen Injectable Product
Primary outcomes (1)
- measure
- Maximally Tolerated Dose
- timeFrame
- MTD will be determined based on DLTs experienced by participants during the first 42 days after administration of 153Sm-DOTMP for Dose Levels 1-3 and during the first 70 days after administration for Dose Levels 4-6
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available