A Safety Study of 212Pb-Pentixather Radioligand Therapy
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYusuf Menda
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 groupSponsors 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