We aimed to assess the clinical efficacy of
glutaraldehyde-fixed human umbilical vein endothelial cell (HUVEC)
vaccine for the treatment of patients with recurrent
glioblastoma. Patients of a HUVEC
vaccine group received
intradermal injections of 5 × 10(7) HUVEC weekly during the first month, and every 2 weeks from the second month, until progression of the disease was observed.
Salvage treatment consisted of multimodal
chemotherapy, radiation, including gamma-knife
therapy, and/or repeated surgery, when feasible. Hazard ratios for death were calculated using a Cox model. A total of 17 patients with recurrent
glioblastoma were enrolled in this study. All the patients received the initial treatment consisting of maximal safe surgical resection, followed by
radiotherapy of 50-80 Gy or more, with concomitant and
adjuvant chemotherapy consisting of
temozolomide or
nimustine (
ACNU). A total of 352 vaccinations were performed for the patients of the HUVEC
vaccine group (median number of vaccination = 11 doses; range 3-122 doses). The median progression-free survival and overall survival were 5.5 and 11.4 months, respectively. The median overall survival from the diagnosis was 24.3 months. The HUVEC vaccine therapy significantly prolonged the
tumor doubling time and contributed to reducing the
tumor growth rate. Hematological adverse reactions due to
chemotherapy were recognized: one patient experienced grade III
leukocytopenia and one showed grade II
lymphocytopenia. Associated with the HUVEC vaccine therapy, a delayed-type
hypersensitivity-like skin reaction developed at the injection site. The HUVEC vaccine therapy effectively controlled
disease progression, without evident adverse effects, except for a delayed-type
hypersensitivity-like skin reaction at the injection site.