Overview
A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-09-01
2024-09-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Albert Einstein College of Medicine
David LoebCollaborator:
National Cancer Institute (NCI)Treatments:
Calcium
Calcium Carbonate
Calcium, Dietary
JM 3100
Plerixafor
Radiopharmaceuticals
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.