Stage IV Skin Melanoma Clinical Trial
Official title:
Interleukin-2 Imaging as a Guide to Cancer Immunotherapy (Ipilimumab or Pembrolizumab) in Advanced Melanoma: A Pilot Study
This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures, such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a scanner to make detailed pictures of areas inside the body and may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells and may be able to differentiate between tumor growth due to inflammation versus tumor progression in patients with stage IV melanoma receiving therapy.
PRIMARY OBJECTIVES:
I. Feasibility/biodistribution of 99mTc-HYNIC-IL2 (technetium Tc 99
hydrazinonicotinamide-tricine-linked interleukin 2) scintigraphy in patients with metastatic
melanoma undergoing immunotherapy with either ipilimumab (commercial source) or
pembrolizumab.
SECONDARY OBJECTIVES:
I. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with
tumor burden; and description of any clinical side effects associated with imaging.
TERTIARY OBJECTIVES:
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.
OUTLINE: Patients are assigned to 1 of 2 groups. COHORT I: Patients undergo technetium Tc 99
hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab
or pembrolizumab and at 12 weeks.
COHORT II: Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked
interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab, at 3-4 weeks, and
at 12 weeks.
After completion of study treatment, patients are followed up at 30-45 days.
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