TY - JOUR
T1 - Autologous large multivalent immunogen vaccine in patients with metastatic melanoma and renal cell carcinoma
AU - Dudek, Arkadiusz Z.
AU - Mescher, Matthew F.
AU - Okazaki, Ian
AU - Math, Vivek T.
AU - Luo, Xianghua
AU - Curtsinger, Julie M.
AU - Miller, Jeffrey S.
PY - 2008/4/1
Y1 - 2008/4/1
N2 - OBJECTIVE: To evaluate the safety and activity of large multivalent immunogen (LMI), prepared by immobilizing autologous tumor cell plasma membrane on 5-μm diameter silica beads, in patients with melanoma and renal cell carcinoma (RCC). METHODS: Thirty patients with stage IV metastatic melanoma and 31 patients with stage IV RCC were randomly assigned to 1 of 3 trial arms and received monthly treatment with (1) LMI alone, (2) cyclophosphamide followed 8 days later with LMI, or (3) the same treatment as in arm 2 with IL-2 given for 5 days beginning 1 week after LMI administration. RESULTS: No grade 4 toxicities were observed. For patients with melanoma, median overall survival time for all 30 patients was 20.4 months [95% confidence interval (CI): 8.0-not assessable], and median progression-free survival was 2.8 months (95% CI: 1.9-6.3). For patients with RCC, median overall survival exceeded 46.2 months (95% CI: 30.3-not assessable), and median progression-free survival was 12.2 months (95% CI: 4.6-not assessable). Two patients had a partial response to LMI treatment. CONCLUSIONS: Based on our results that demonstrate the safety and tolerability of LMI vaccine, further development of this therapy is warranted to evaluate its clinical efficacy.
AB - OBJECTIVE: To evaluate the safety and activity of large multivalent immunogen (LMI), prepared by immobilizing autologous tumor cell plasma membrane on 5-μm diameter silica beads, in patients with melanoma and renal cell carcinoma (RCC). METHODS: Thirty patients with stage IV metastatic melanoma and 31 patients with stage IV RCC were randomly assigned to 1 of 3 trial arms and received monthly treatment with (1) LMI alone, (2) cyclophosphamide followed 8 days later with LMI, or (3) the same treatment as in arm 2 with IL-2 given for 5 days beginning 1 week after LMI administration. RESULTS: No grade 4 toxicities were observed. For patients with melanoma, median overall survival time for all 30 patients was 20.4 months [95% confidence interval (CI): 8.0-not assessable], and median progression-free survival was 2.8 months (95% CI: 1.9-6.3). For patients with RCC, median overall survival exceeded 46.2 months (95% CI: 30.3-not assessable), and median progression-free survival was 12.2 months (95% CI: 4.6-not assessable). Two patients had a partial response to LMI treatment. CONCLUSIONS: Based on our results that demonstrate the safety and tolerability of LMI vaccine, further development of this therapy is warranted to evaluate its clinical efficacy.
KW - Autologous vaccine
KW - Large multivalent immunogen vaccine
KW - Metastatic kidney cancer
KW - Metastatic malignant melanoma
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U2 - 10.1097/COC.0b013e3181573e6b
DO - 10.1097/COC.0b013e3181573e6b
M3 - Article
C2 - 18391603
AN - SCOPUS:42049105857
VL - 31
SP - 173
EP - 181
JO - American Journal of Clinical Oncology
JF - American Journal of Clinical Oncology
SN - 0277-3732
IS - 2
ER -