PURPOSE The clinical setting of stage IV melanoma is not optimal for testing the effects of immunotherapeutic interventions. In order to explore the therapeutic effect of recombinant interleukin 21 (rIL-21) in the earlier stages of disease, we tested local subcutaneous (sc) administration of rIL-21 in a clinical setting of early stage III malignant melanoma. EXPERIMENTAL DESIGN The pilot trial was planned to enroll 20 patients with stage III melanoma as identified by high-resolution ultrasonography and fine-needle aspiration cytology (FNAC). Patients would receive rIL-21 administered sc in the area of the primary lesion for 4 weeks in a thrice-weekly regimen prior to complete regional lymph node dissection. Subsequently, patients would receive rIL-21 administered sc systemically for 8 weeks as adjuvant therapy. RESULTS Only one patient was entered in the trial, as the sponsor withdrew the trial for company strategic reasons. The patient, a 45-year-old male, completed the 4 weeks of local neoadjuvant rIL-21 therapy and underwent complete regional lymph node dissection. A total of 28 lymph nodes were examined by extensive slicing and histological examination involving immune histochemical staining with Melan-A and HMB-45. No signs of micro- or macrometastatic disease were observed. CONCLUSION Although only one patient entered the trial, local and sc administration of rIL-21 was shown to have clear immunomodulatory effects in the tumor-draining lymph nodes and resulted in a complete response, as assessed by histological examination of the resected lymph nodes. This observation may have implications for future immunotherapeutic interventions in patients with melanoma.

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Asia-Pacific Journal of Oncology and Hematology
Department of Surgery

Schäfer-Hesterberg, G, Guerreiro, M, Mouritzen, U, Kowalczyk, K, Meisel, C, Haase, O, … Voit, C. (2010). Ultrasound-Guided Fine-Needle aspiration cytology (USFNAC) to detect melanoma cells in the sentinel node facilitates local administration of medication, here IL-21 (rIL21) in a novel neoadjuvant setting into the sentinel node of stage III Melanoma Patients. Asia-Pacific Journal of Oncology and Hematology, 2(2). Retrieved from http://hdl.handle.net/1765/89267