A Dose Finding Study to Treat Bone Tumor(s) (NCT06008483) | Clinical Trial Compass
UnknownPhase 1
A Dose Finding Study to Treat Bone Tumor(s)
United States17 participantsStarted 2022-04-05
Plain-language summary
To determine the Maximum Tolerated Dose (MTD) of CycloSam®, Samarium-153-DOTMP (Sm-153-DOTMP), a radiopharmaceutical that delivers radiation to the bone when injected, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan.
Who can participate
Age range15 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects will be between the ages of 15 and 75, inclusive.
✓. Subjects must have a histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of a solid tumor to the bone or metastatic to the bone.
✓. Subjects 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 organ function, including:
✓. Life expectancy of at least eight weeks.
✓. Karnofsky performance status \>50%.
✓. Subjects 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 CTCAE v5.0 grade ≤1. Subjects with Grade 2 anemia per CTCAE v5.0 will be permitted as long as the subject has normal cardiac function.
✓. Adequate cardiac function. Subjects 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.
Exclusion criteria
✕. Subject is pregnant or breastfeeding.
✕. Subject is sexually active and does not agree to use accepted, effective forms of contraceptive.