TITLE:
A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Primary Brain Tumors—Final Report (Protocol BT-09)
AUTHORS:
Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski
KEYWORDS:
Anaplastic Astrocytoma, Antineoplastons A10 and AS2-1, Low-Grade Astrocytoma, Phase II Clinical Trial, Tectal Glioma
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.6 No.12,
November
25,
2015
ABSTRACT: Antineoplastons A10 and AS2-1 (ANP) are synthetic derivatives of
glutamine, isoglutamine, and phenylacetic acid. In 1993, a phase II clinical
trial program began according to protocols based on the initial protocol, BT-06,
which was transferred from the National Institutes of Health (NIH). Protocol
BT-09 was designed for different types of primary brain tumors in adults that
were not curable by standard treatment. The study was designed as a single arm,
two-stage, phase II trial of ANP as a monotherapy in a high-risk,
poor-prognosis population. The total number of registered subjects was 40. The
majority of patients were diagnosed with high-grade tumors (N = 33). In this group, 12 patients
carried diagnosis of anaplastic astrocytoma (AA) and 11 patients of
glioblastoma. In the group of low-grade tumors (N = 7), there were 6 cases of low-grade glioma, and 1 neurocytoma
grade 2. A group of 12 patients did not receive any prior treatment, 12 patients
had surgical resection only, 5 patients received radiation therapy (RT) only,
and 11 patients received both RT and chemotherapy. The median duration of ANP
was 16.6 weeks. The median dosage of A10 was 7.16 g/kg/d and AS2-1 was 0.27
g/kg/d. Responses were accessed by gadolinium-enhanced magnetic resonance
imaging (MRI). Objective responses (OR) in all patients were 22.5% and in the
AA group were 41.7% of patients. The median progression-free survival (PFS) in
the AA group was 5.4 months. The median overall survival (OS) was 12.7 months
and OS at 1 and 2 years was 54.5% and 45.5% correspondingly. The treatment was
well-tolerated with reversible grade 3 and 4 toxicities in 35% of all patients
(N = 40). In conclusion, the study
reached efficacy endpoint and ANP was well-tolerated and compared favorably to
the current treatment of AA.