This phase I trial tests the safety, side effects and best dose of tin (Sn)-177m-diethylenetriaminepentaacetic acid (DTPA) and how well it works in treating prostate, breast or non-small cell lung cancer that has spread from where it first started (primary site) to the bones (bone metastases). Sn-117m-DTPA was originally tested in tumors that had spread to the bones to help reduce bone pain. The drug has been improved and is designed to send low-level radiation to tumors in the bone while being gentler on the bone marrow, where blood cells are made. Sn-117m-DTPA may be safe and tolerable, and may slow down or shrink tumors in patients with metastatic prostate, breast, or non-small cell lung cancer that has spread to the bones.
Histologically documented prostate, breast, or non-small cell lung cancer (NSCLC)
Metastatic disease in bone only (patients with visceral disease, cutaneous disease or malignant lymph nodes > 3 cm in largest diameter are not eligible)
Documented disease progression (1 or more new bone lesion or enlargement of existing bone lesion, identified by Tc-99m bone scintigraphy or CT scan, magnetic resonance imaging [MRI], fludeoxyglucose F-18 [FDG] PET CT scan or PSMA PET CT scan)
Must have progression on at least one line of standard of care systemic therapy. There are no maximum number of prior therapies
Patients who have not recovered from reversible adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
Patients must not have received any investigational agents within 4 weeks or 5 half-lives, whichever is shorter, before starting study treatment, nor be scheduled to receive one during the planned treatment period
Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sn-117m-DTPA
Patients must not have imminent or established spinal cord compression, pathological fracture in weight bearing bones, or bone lesion with soft tissue component unless treated as appropriate with radiation and/or surgery before starting on this study
Single group
Biospecimen Collection
Procedure/SurgeryUndergo urine and blood sample collection
Bone Scan
Procedure/SurgeryUndergo technetium TC-99m bone scan
Computed Tomography
Procedure/SurgeryUndergo PET/CT, SPECT/CT and PSMA PET/CT
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
PSMA PET Scan
Procedure/SurgeryUndergo PSMA PET/CT
Single Photon Emission Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Technetium TC-99m
RadiationUndergo technetium TC-99m bone scan
Tin Sn 117m Pentetate
RadiationGiven IV
Frequency of dose-limiting toxicities
Will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized by severity grade, system organ class, and their relation to study treatment.
Frequency of adverse events
Will be graded using NCI CTCAE v 5.0. Will be summarized by severity grade, system organ class, and their relation to study treatment.
Tumor response
Will be evaluated using prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) for prostate cancer and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) for breast and non-small cell lung cancers. Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point.
Time to first symptomatic skeletal event
Will be defined as the first use of external-beam radiation therapy to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression or tumor-related orthopedic surgical intervention. Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be analyzed using the Kaplan-Meier product limit method. Estimation and confidence intervals for the median time to first symptomatic skeletal event will be provided.
Changes in serum PSA (prostate cancer patients only)
Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be calculated for each of the above defined categories with the corresponding confidence intervals.
Time to progression in serum PSA (prostate cancer patients only)
Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be calculated for each of the above defined categories with the corresponding confidence intervals.
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