This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and previously treated, for atypical carcinoid lesions of the lung.
This is a study to determine what dose is acceptably safe for further testing. In this study, participants are asked to: * undergo SPECT/CT imaging with Lead-203 Pentixather (a radiotracer) to ensure the tumor lesions have the needed receptors * undergo serial blood sampling for during and after the SPECT/CT scan for radiation and dosimetry calculations (to determine how much of the Lead-212 Pentixather to administer) * receive up to 2 infusions of arginine \& lysine as a kidney protectant * receive up to 2 infusions of Lead-212 Pentixather, 6 weeks between each infusion * undergo imaging at 3 months post treatment to determine disease response
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.
University of Iowa Health Care
Iowa City, Iowa, United States
Determine the recommended phase 2 dose of 212-Lead Pentixather
The recommended phase 2 dose is based on the number of dose limiting toxicities observed post-treatment.
Time frame: 3 months
Determine the targeting of atypical pulmonary neuroendocrine tumor and/or neuroendocrine carcinoma lesions with 203-Lead Pentixather SPECT/CT
The number of lesions identified with 203-Lead Pentixather SPECT/CT will compared to FDG PET/CT and diagnostic CT scans at baseline.
Time frame: baseline
Determine tumor response
Tumor response will be assessed using the Response Evaluation Criteria in Solid Tumours (RECIST, v 1.1).
Time frame: 3 months
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