A Phase II Study of Antineoplastons A10 and AS2-1 Injections in Adult Patients With Recurrent Anaplastic Astrocytoma—Final report (Protocol BT-15)

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

Abstract


The recommended treatment for recurrent anaplastic astrocytoma (AA) consists of chemotherapy with temozolomide. There is an urgent need for new therapies for such patients. This phase II study evaluates efficacy and safety of a different form of cancer therapy that consists of antineoplastons A10 and AS2-1 (ANP). 27 patients, ages 19 to 57 years (median, 41) with recurrent AA were treated. All patients previously underwent surgery, all received radiation therapy, and 16 underwent chemotherapy. The patients received treatment with ANP administered daily every four hours (median dose of A10 6.0 g/kg/d and AS2-1 0.25 g/kg/d). All patients were included in efficacy and safety analysis. The median duration of ANP was 23.1 weeks. A complete response was documented in 7%, partial response in 11%, and stable disease in 22% of patients. Progression-free survival and overall survival at 12 months was 26% and 41% respectively. The only serious toxicity was Grade 3 reversible hypokalemia in 7% of patients. There was no chronic toxicity and there was a high quality of life. ANP shows efficacy with very good toxicity profile in this cohort of patients with recurrent AA.


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DOI: http://dx.doi.org/10.5539/cco.v4n2p13

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Cancer and Clinical Oncology   ISSN 1927-4858(Print)   ISSN 1927-4866(Online)   Email: cco@ccsenet.org

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