A Safety Study of 212Pb-Pentixather Radioligand Therapy

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