Testing the Safety of the Anti-cancer Drug, Sn-117m-DTPA, for Advanced Cancers That Have Spread to Bones

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Scan
  • Computed Tomography
  • Positron Emission Tomography
  • PSMA PET Scan
  • Single Photon Emission Computed Tomography
  • Technetium TC-99m
  • Tin Sn 117m Pentetate

Treatment groups

24 Participants
are divided into 1 treatment group

Locations

This trial has no locations