TITLE:
Recurrent Glioblastoma Multiforme—A Strategy for Long-Term Survival
AUTHORS:
Stanislaw R. Burzynski, Gregory S. Burzynski, Tomasz J. Janicki
KEYWORDS:
Antineoplastons A10 and AS2-1, Recurrent Glioblastoma Multiforme, HDAC Inhibitor, Phase II Clinical Trials, Glioblastoma Survival, Phenylbutyrate, Targeted Therapy
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.5 No.10,
September
10,
2014
ABSTRACT: Recurrent GBM (RGBM) has a
highly unfavorable prognosis with majority of patients dying within 6 months
and no standard treatments available. Antineoplaston (ANP) A10 and AS2-1
injections underwent Phase II trials in RGBM patients, which reported a
long-term overall survival (OS) in a small percentage of patients. The
additional Phase II studies BT-07, and BT-21 with ANP in GBM also revealed
cases of a long-term OS. ANP shares active ingredients with metabolites of
sodium phenylbutyrate (PB), which was used in private practice setting in
combination of targeted and chemotherapeutic agents for the treatment of RGBM.
The treatment contributed to cases of rapid complete response (CR) and
significant OS. This paper provides case studies of three patients treated with
ANP under Phase II protocols and two patients treated with PB in combination
with targeted therapy, who obtained CR and long-term OS. Based on these studies
and basic research on the effects of ANP and PB on the genome of GBM and review
of results of preclinical and clinical research on targeted agents, the authors
suggest a new strategy for successful treatment of RGBM. They propose Phase
I/II clinical trials with ANP and PB in combination with targeted agents,
bevacizumab (BVZ), pazopanib, dasatinib and everolimus in patients with RGBM
after failure of standard surgery, radiation therapy (RT) and chemotherapy
including temozolomide (TMZ) to be conducted to evaluate survival, response and
toxicity in these patients.