TITLE:
A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low-Grade Astrocytomas—Final Report (Protocol BT-13)
AUTHORS:
Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski
KEYWORDS:
Antineoplastons A10 and AS2-1, Astrocytoma, Low-Grade Astrocytoma, Low-Grade Glioma, Pediatric Brain Tumors, Phase II Clinical Trial
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.7 No.12,
November
4,
2016
ABSTRACT: Nonresectable Low-Grade Astrocytomas (LGA) can compromise function
and threaten life. For the majority of patients, the most appropriate strategy
is initial chemotherapy followed by Radiation Therapy (RT). Since curative
treatment is not available for most of these patients, it is reasonable to
conduct clinical studies to evaluate new agents. This Phase II study evaluates efficacy
and safety of Antineoplastons A10 and AS2-1 (ANP) in LGA. Sixteen children
diagnosed with LGA were treated. They included 12 males and 4 females, ages 1.6 - 17.4 years
(median 10.6). Efficacy was evaluated in 16 patients. The majority of patients
were previously treated, but 1 patient had stereotactic biopsy only. Out of the
remaining 15 patients, 6 patients received chemotherapy, and 7 patients had surgery, and 2 patients received RT and chemotherapy after
surgery. The patients received treatment with ANP administered daily every 4
hours (median dose of A10 was 7.71 g/kg/d and AS2-1 was 0.26 g/kg/d) until
objective response or stable disease was documented and for 8 months
thereafter. The duration of ANP IV ranged from 1.4 to 286 weeks with a median
of 83 weeks. A complete response was documented in 25.0%, partial response in 12.5%,
and stable disease in 37.5%. Overall survival was 67.7% at 5 years, and 54.2%
at 10 and 15 years. Progression-free survival was 48.1%, 34.4% and 34.4% at 5, 10, and 15 years
respectively. The treatment was associated with grade 3 or grade 4 Adverse Drug
Experiences (ADE) in 6 patients. There were two hypernatremias of grade 4
(12%). Grade 3 ADE included urinary frequency (6%), fatigue (6%) and
hypernatremia (6%). There were no chronic toxicities, and there was a high
quality of survival. ANP shows efficacy with a very good toxicity profile in
this cohort of children with low-grade astrocytoma.