TITLE:
A Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Brainstem Gliomas. The Report on Non-Diffuse Intrinsic Pontine Glioma (Protocol BT-11)
AUTHORS:
Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski, Ania Marszalek
KEYWORDS:
Antineoplastons A10 and AS2-1, Brainstem Glioma, Diffuse Intrinsic Pontine Glioma, Phase 2 Clinical Trial, Recurrent Glioma
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.6 No.4,
April
13,
2015
ABSTRACT: Inoperable brainstem gliomas (BSG) are among the
most difficult to treat malignancies. In the intent-to-treat (ITT) population
of the BT-11 study for BSG, forty patients (median age 11.2 years old) were
enrolled. Antineoplastons A10 and AS2-1 (ANP) were administered intravenously
daily. The median daily dose of A10 was 8.70 g/kg/day and AS2-1 was 0.32 g/kg/day.
Efficacy analyses were conducted in two subgroups: recurrent pediatric diffuse
intrinsic pontine glioma (RPDIPG, N= 17) and non-diffuse intrinsic
pontine glioma (NDIPG, N= 11). This paper reports the results of
the study of the efficacy and safety of ANP in patients with NDIPG. The results
in the RPDIPG group were reported before; complete response (CR) was 6%,
partial response (PR) 23.5%, and stable disease (SD) 17.6%. One year overall
survival (OS) was 29.4%, 2 years 11.8%, and 5, 10, and 15 years 6%. In the
NDIPG group, there were 36% CR and 27.5% SD. OS at 1, 5, 10, and 15 years was
82%, 73%, 62%, and 50% correspondingly. There was only one serious adverse
event (9%) reported in NDIPG represented by hypokalemia, Grade 4. The results
suggest that ANP shows efficacy and an acceptable tolerability profile in
patients with RPDIPG and NDIPG.