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Phase I/IIa trial of autologous formalin-fixed tumor vaccine concomitant with fractionated radiotherapy for newly diagnosed glioblastoma. Clinical article.

Authors :
Muragaki Y
Maruyama T
Iseki H
Tanaka M
Shinohara C
Takakura K
Tsuboi K
Yamamoto T
Matsumura A
Matsutani M
Karasawa K
Shimada K
Yamaguchi N
Nakazato Y
Sato K
Uemae Y
Ohno T
Okada Y
Hori T
Source :
Journal of neurosurgery [J Neurosurg] 2011 Aug; Vol. 115 (2), pp. 248-55. Date of Electronic Publication: 2011 May 13.
Publication Year :
2011

Abstract

Object: The objective of the present study was analysis of results of the prospective clinical trial directed toward the evaluation of therapeutic efficacy of the administration of autologous formalin-fixed tumor vaccine (AFTV) concomitant with fractionated radiotherapy in cases of newly diagnosed glioblastoma multiforme.<br />Methods: Twenty-four patients were enrolled into the clinical trial, while 2 cases were excluded from the final analysis of results. The treatment protocol included aggressive tumor resection, fractionated radiotherapy up to a total dose of 60 Gy, and 3 concomitant courses of AFTV administered with an interval of one week at the late stage of irradiation. Two delayed-type hypersensitivity (DTH) tests were done--one 48 hours before the initial course of vaccination (DTH-1) and one 2 weeks after the third (DTH-2). All but one of the patients received salvage therapy at the time of tumor progression. The defined primary end point was overall survival; secondary end points were progression-free survival and safety of concomitant treatment.<br />Results: The median duration of overall survival was 19.8 [corrected] months (95% CI 13.8-31.3 months). The actuarial 2-year survival rate was 40%. The median duration of progression-free survival was 7.6 months (95% CI 4.3-13.6 months). Overall survival showed a statistically significant association with recursive partitioning analysis class (p < 0.05); progression-free survival showed a statistically significant association with p53 staining index (p < 0.05) and size of DTH-2 response (p < 0.001). AFTV injection concomitant with fractionated radiotherapy was well tolerated by all patients and in no case did treatment-related adverse effects exceed Grade 1 toxicity; adverse effects were limited to local erythema, induration, and swelling at the site of injection.<br />Conclusions: The results of this study demonstrate that AFTV treatment concomitant with fractionated radiotherapy may be effective in patients with newly diagnosed glioblastoma. Further clinical testing is warranted.

Details

Language :
English
ISSN :
1933-0693
Volume :
115
Issue :
2
Database :
MEDLINE
Journal :
Journal of neurosurgery
Publication Type :
Academic Journal
Accession number :
21568657
Full Text :
https://doi.org/10.3171/2011.4.JNS10377