Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

ability to provide independent consent

adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g/dL; neutrophil count ≥ 1,500 cells/mm3)

adequate kidney function (creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault equation

adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x the upper limit of normal, and ALT ≤ 5x the upper limit of normal)

Disqualifiers

major surgery within 4 weeks of consent

antoher investigational agent within 4 weeks of consent

uncontrolled illness including, but not limited to, ongoing or active infection that would necessitate a delay in therapy or cause a hospital admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic cirrhosis or severe impairment, or psychiatric illness/social situations that would limit compliance with study requirements.

prior solid organ transplant

Trial design

Treatments tested in this trial

  • 212-Lead Pentixather
  • 203-Lead Pentixather SPECT/CT

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1
University of Iowa Health Care52242, Iowa CityIowa, United States

Sponsors and collaborators

Yusuf Menda

Lead sponsor

University of Iowa

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Holden Comprehensive Cancer Center

Collaborator

Source ClinicalTrials.gov