Interleukin-2 Imaging As A Guide To Cancer Immunotherapy (Ipilimumab) In Advanced Melanoma: A Pilot Study
I. Feasibility/biodistribution of 99mTc-HYNIC-IL2 (technetium Tc 99
hydrazinonicotinamide-tricine-linked interleukin 2) scintigraphy in patients with metastatic
melanoma undergoing ipilimumab (IPI) therapy.
I. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with
tumor diameter (Response Evaluation Criteria in Solid Tumors [RECIST]); description of
survival end points(progression free survival [PFS]/overall survival [OS] and 2 year
survival rate); and description of any clinical side effects associated with imaging.
I. Correlation of TIL invasion assessed by 99mTc-HYNIC-IL2 scintigraphy vs histology (total
and subsets of TIL), as well as screen for peripheral blood correlates.
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2
scintigraphy prior to receiving ipilimumab therapy and at 12 weeks.
After completion of study treatment, patients are followed up every 3 months for up to 2
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Proportion of patients who develop a SLD (grade 2+ allergic reaction; grade 3+ anaphylaxis, grade 2+ injection site reaction, or a grade 3+ non-hematologic toxicity -not attributed to IPI treatment/progression or a co-morbid condition)
95% binomial confidence interval will be constructed
Up to 12 weeks
United States: Food and Drug Administration
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