Patient population
AJCC) Stage II, malignancy, malignant cutaneous melanoma, organ dysfunction, infection, skin cancer, Hepatitis B, Cancer
ADVERSE EVENT, OCULAR MELANOMA, BLOOD, ADVERSE EVENT, MALIGNANT CUTANEOUS MELANOMA, RECRUITMENT, INFECTION, SKIN CANCER, ONCOLOGY, HEPATITIS B, CANCER OF THE CERVIX, CANCER
Patients with histologically confirmed, fully resected American Joint Committee on Cancer (AJCC) Stage II, III or IV malignant cutaneous melanoma who were: ≥ 18 years old; no more than 12 months post-surgery; at least two weeks since most recent surgery; Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; and had normal full blood counts and renal and liver function biochemistry. Patients were excluded if they had: mucosal or ocular melanoma; received prior chemotherapy or radiotherapy within 6 weeks of recruitment; received prior immunotherapy, been diagnosed with another malignancy in the past 3 years (except non-melanoma skin cancer or in situ cancer of the cervix); active infection with Hepatitis B, C or Human immunodeficiency virus (HIV); uncontrolled or unstable autoimmune disease; previous use of long-term immunosuppressive therapy before leukapheresis; co-morbid conditions that would require long-term use (> 1 month) of systemic corticosteroids during study treatment; concurrent major organ dysfunction or other unstable medical condition; or were pregnant or breastfeeding. Patients were recruited by the Wellington Blood and Cancer Centre (WBCC) or Auckland City Hospital.Eligible patients who gave written informed consent underwent leukapheresis to provide peripheral blood mononuclear cells (PBMCs) from which monocyte-derived DCs were generated, with a maximum of 12 weeks to prepare the vaccine and start study treatment. Both DCV and DCV + All clinical procedures and assessments were carried out at WBCC, except for day 1 and day 15 blood draws for Auckland-based patients. Clinical assessments were undertaken at screening and with each vaccine visit until the end of study (28 days after the last vaccination). Adverse events were recorded from the date of consent until end of the study treatment and coded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). For analysis of T cells and NKT cells, blood was collected 1–6 days before treatment was initiated, immediately before each vaccination, 24 h after vaccination, and 2 and 4 weeks after vaccination. Blood was collected for analysis of serum cytokines 2 days before treatment was initiated, immediately before each vaccination, and 6 h and 24 h after vaccination. Blood samples were enriched for PBMCs within 6 h of collection and immediately cryopreserved for later analysis. Methodology for vaccine manufacture and immune analysis are provided in Supplementary Materials and Methods.