Autologous large multivalent immunogen vaccine in patients with metastatic melanoma and renal cell carcinoma.
OBJECTIVE
To evaluate the safety and activity of large multivalent immunogen (LMI), prepared by immobilizing autologous tumor cell plasma membrane on 5-microm 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.
Dudek
Arkadiusz Z
AZ
Division of Hematology, Oncology and Transplantation, University of Minnesota, 420 Delaware St. SE, MMC 480, Minneapolis, MN 55455, USA. dudek002@umn.edu
Mescher
Matthew F
MF
Okazaki
Ian
I
Math
Vivek T
VT
Luo
Xianghua
X
Curtsinger
Julie M
JM
Miller
Jeffrey S
JS
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000951:Antigens, Neoplasm / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D019496:Cancer Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage; D007680:Kidney Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D012878:Skin Neoplasms / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis
D000951:Antigens, Neoplasm; D000970:Antineoplastic Agents; D019496:Cancer Vaccines; D007376:Interleukin-2; D003520:Cyclophosphamide