NCT03612466

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a dose escalation study of a new radiopharmaceutical agent, 153Sm-DOTMP. Eligible participants will have osteosarcoma metastatic to bone, other solid tumors with bone metastases, or an unresectable localized osteosarcoma. Because of anticipated prolonged myelosuppression, participants will have a peripheral blood stem cell harvest. They will then be treated with 2 doses of 153Sm-DOTMP given 7 days apart. Twenty-four days after the initial dose, stem cells will be reinfused if needed. The first three cohorts of participants will receive only radiopharmaceutical. If Dose Level 3 is not the maximally tolerated dose (MTD), subsequent dose levels will include external beam radiotherapy, administered beginning on Day 15. The dose of external beam radiotherapy will be determined by dosimetry studies performed after each administration of study agent, and will be targeted to a tumoricidal dose of radiation. All participants will have disease re-evaluation 30 days following completion of all study treatments, and then at 4, 6, 8, and 12 months, unless they experience disease progression.

Conditions

• Osteosarcoma
• Bone Metastases

Interventions

Type	Name	Description
DRUG	153Sm-DOTMP	For Levels 1- 3, the Day 1 dosages will be the same (0.5 millicurie (mCi)/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 0.5, 1.0 and 3.0 mCi/kg respectively. For Levels 4, 5 \& 6, the Day 1 dosages will be the same (0.5 mCi/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 3, 6, then 10 mCi/kg 153Sm-DOTMP respectively.
RADIATION	External beam radiotherapy.	The amount of radiation will be determined based on how much radiation was delivered to each tumor by the 153Sm-DOTMP, and will be targeted to 70 Gray (Gy)
DRUG	Calcium Carbonate	Calcium carbonate will be given to participants as prophylaxis against hypocalcemia..
DRUG	Mozobil	Participants who require stem cell collection will be given Mozobil to help mobilize hematopoietic stem cells into the circulation for collection.
DRUG	Neupogen Injectable Product	Participants who require stem cell collection will be given Neupogen to help mobilize hematopoietic stem cells into the circulation for collection.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-01-01
• Completion: 2024-09-01
• First posted: 2018-08-02
• Last updated: 2022-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study