A Safety Study of 212Pb-Pentixather Radioligand Therapy

Launched by YUSUF MENDA · Sep 23, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called 212Pb-Pentixather, which uses a type of radiation to target specific tumors in the lungs, particularly for patients with carcinoid tumors or neuroendocrine tumors who have already been treated before. The main goal of this study is to ensure the safety of this treatment in people who have these types of lung tumors.

To participate in this trial, patients need to be between the ages of 65 and 74 and should be able to give consent for themselves. They must also have certain health criteria, like good blood, kidney, and liver function, and have at least one tumor that is a certain size and shows a specific marker on scans. Participants can expect regular check-ups to monitor their health and the effects of the treatment. It’s important to know that some health conditions or recent treatments may prevent someone from joining the trial, and women who are pregnant or breastfeeding cannot participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• • failed initial therapy or declined further therapy known to confer benefit
• • have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT/CT
• Exclusion Criteria:
• • 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
• • cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas)
• • antibody therapy within the 21 days of consent
• • allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84 days of consent
• • pregnancy
• • breastfeeding
• • refusal to comply with birth control requirements during study