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.
This is an open-label, unblinded, multi-center, dose-finding study of 153-Sm-DOTMP (CycloSam®), a radiopharmaceutical that delivers radiation to the bone when injected, to identify the MTD of 153-Sm- DOTMP, given as a tandemly administered pair of doses to subjects with solid tumors visible on bone scan. The MTD will be defined as the dose level that produces a dose limiting toxicity (DLT) rate no greater than 25%. DLTs will be defined as any grade 3 or greater hematologic or nonhematologic toxicity, as defined by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), experienced during a 42 day observation window. Clinical response will be defined as either stable disease (SD) or a decrease in the size of the tumor by radiographic imaging (which may include computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.The Day 1 dose will remain constant at 0.5 mCi/kg, with the Day 8 dose escalated from 0.5 mCi/kg (dose level 1) to 1.0 mCi/kg (dose level 2) to 2.0 mCi/kg (dose level 3) and then to 3.0 mCi/kg (dose level 4).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
This is an open-label, unblinded, multi-center, dose-finding study of 153Sm-DOTMP (CycloSam®) to identify the MTD of 153Sm- DOTMP, given as a tandemly administered pair of doses to subjects with solid tumors visible on bone scan.
Clinical Trial Site
Chicago, Illinois, United States
RECRUITINGClinical Trial Site
Columbia, Missouri, United States
ACTIVE_NOT_RECRUITINGClinical Trial Site
New Brunswick, New Jersey, United States
RECRUITINGDose Limiting Toxicity Rate (DLT)
The primary endpoint is defined as the DLT rate observed during a 42-day window following administration of 153-Sm-DOTMP for each dose level. DLTs will be defined as any grade 3 or greater hematologic or nonhematologic toxicity, as defined by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), experienced during a 42 day observation window. The MTD (Maximum Tolerated Dose) will be defined as the dose level that produces a dose limiting toxicity (DLT) rate no greater than 25%.
Time frame: 42 Days
Bone Tumor Efficacy - Clinical Response Rate
Clinical response rate - defined as either SD or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST v1.1 criteria with the tumor measured in mm by days and months.
Time frame: Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
Overall Survival
Overall survival - defined as the time from start of treatment to death due to any cause as measured in days and months
Time frame: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
Time to Progression
Time to progression - defined as the time from start of treatment to appearance of new lesions or expansion of current lesions by 20% as per RECIST v1.1 criteria in mm of tumor and by days and months
Time frame: Day 42, 68, 4 months, 8 months, 12 months, 24 months, and 36 months
Pain Palliation
Pain palliation as assessed per the pain VAS as measured in mm of length of a 100 mm Visual Analog Pain Scale by days and months
Time frame: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months
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Clinical Trial Site
Houston, Texas, United States
RECRUITINGSafety Based on Number of Treatment Emergent Adverse Events
Safety based on the number of Treatment Emergent Adverse event (TEAEs), as measured by the number of these events by days and months.
Time frame: Day 38, 42, 68, 4 months, 6 months, 8 months, 12 months, 24 months, and 36 months