A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors

Inclusion Criteria

• •Ability to understand and willingness to provide informed consent
• •Stated willingness to comply with all study procedures and availability for duration of study
• •Aged ≥ 18 years to 80 years at the time of study drug administration
• •Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2)
• •Disease not amenable to curative intent treatment (e.g., surgery) and in addition, has shown either clinical or radiographic progression on all available therapies known to confer clinical benefit in the opinion of the referring physician. If a patient is suspected of experiencing a clinical non-response to current treatment (i.e., the patients clinical symptomatology has not improved despite treatment) the patient may be included if confirmed by the study investigator.
• •Prior peptide receptor radionuclide therapy (PRRT)
• •Positive somatostatin receptor (SSTR) PET/CT utilizing an FDA approved agent within 12 months prior to anticipated day 1 of treatment demonstrating SSTR positive tumor sites.
• •≥1 evaluable site of disease measuring ≥ 1.0 cm in diameter on CT or MRI as measured per RECIST
• •Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
• •No other active malignancy that requires immediate treatment. Slow growing concurrent cancers (such as prostate cancer) are acceptable with appropriate documentation from their treating oncologists for that primary.
• •Not experiencing an uncontrolled intercurrent illness such as: infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
• •Agreement to adhere to Lifestyle Considerations throughout study duration:
• •During this study, participants are asked to:
• •Refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice, \[pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices\] from the day prior to therapy through 5 days post-treatment.
• •Comply with their antihypertensive medications, if prescribed.
• •Refrain from excessive alcohol use.
• •Refrain from "natural" or "herbal" supplements unless approved by the treating physician and research team.
• •Utilize contraception for at least 6 months in uterine-bearing patients and at least 3 months in testes-bearing patients.