A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low-Grade Astrocytomas—Final Report (Protocol BT-13) - Journal of Cancer Therapy

JCT > Vol.7 No.12, November 2016

Volume 7, Issue 12 (November 2016)

ISSN Print: 2151-1934 ISSN Online: 2151-1942

Google-based Impact Factor: 0.35 Citations

A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low-Grade Astrocytomas—Final Report (Protocol BT-13) ()

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DOI: 10.4236/jct.2016.712083 1,539 Downloads 3,258 Views Citations

Author(s)

Stanislaw R. Burzynski^*, Tomasz J. Janicki, Gregory S. Burzynski

Affiliation(s)

Burzynski Clinic, Houston, TX, USA.

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.

KEYWORDS

Antineoplastons A10 and AS2-1, Astrocytoma, Low-Grade Astrocytoma, Low-Grade Glioma, Pediatric Brain Tumors, Phase II Clinical Trial

Share and Cite:

Burzynski, S. , Janicki, T. and Burzynski, G. (2016) A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low-Grade Astrocytomas—Final Report (Protocol BT-13). Journal of Cancer Therapy, 7, 837-850. doi: 10.4236/jct.2016.712083.

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