A Safety Study of 212Pb-Pentixather Radioligand Therapy

This is a study to determine what dose is acceptably safe for further testing.

In this study, participants are asked to:

• undergo SPECT/CT imaging with Lead-203 Pentixather (a radiotracer) to ensure the tumor lesions have the needed receptors
• undergo serial blood sampling for during and after the SPECT/CT scan for radiation and dosimetry calculations (to determine how much of the Lead-212 Pentixather to administer)
• receive up to 2 infusions of arginine & lysine as a kidney protectant
• receive up to 2 infusions of Lead-212 Pentixather, 6 weeks between each infusion
• undergo imaging at 3 months post treatment to determine disease response

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