Another study by the developer and associates reported on the long-term survival of high-risk pediatric patients with central nervous systemprimitive neuroectodermal tumors treated with a combination of AS2-1 and A10 for an average duration of 20 months (range, 1.2-67 months). The average dose of A10 was 10.3 g/kg daily, and the average dose of AS2-1 was 0.38 g/kg daily. Of 13 patients (age range, 1-11 years) with recurrent or high-risk disease given intravenous infusions of the antineoplaston combination, six patients survived more than 5 years from the start of antineoplaston therapy, and three of these six survived more than 7 years. These three patients received no chemotherapy or radiation after their initial partial tumor resection and before treatment with antineoplastons. A complete response was seen in two of the long-term survivors. Reported adverse effects included fever, granulocytopenia (reversible), and anemia.
A 2006 report from the developer and associates summarizes the results from four phase II trials of antineoplaston treatment for high-grade, recurrent, and progressive brainstem glioma. Two of the 18 patients in this report were included in a previously published study. Patients were treated with a combination of AS2-1 and A10 for an average of 216 days (range, 1.53-18.36 months). Doses of A10 ranged from 0.78 g/kg daily to 19.44 g/kg daily; doses of AS2-1 ranged from 0.2 g/kg daily to 0.52 g/kg daily.
Complete responses were observed in two cases, partial response in two cases, stable disease in seven cases, and progressive disease in seven cases. Reversible anemia, the only reported adverse effect, occurred in three patients. Survival from the start of antineoplaston treatment ranged from 2.6 months to 68.4 months among the newly reported cases.
A phase II clinical trial using antineoplaston AS2-1 in conjunction with low-dose diethylstilbestrol (DES) was conducted by the developer and his associates in 14 patients with hormonally refractoryprostate cancer. Thirteen patients were diagnosed with stage IV prostate cancer, and one patient was diagnosed with stage II prostate cancer. Ages ranged from 54 to 88 years. Previous therapy included prostatectomy, orchiectomy, radiation therapy, and treatment with DES, luteinizing hormone-releasing hormone (LHRH) agonists, flutamide, aminoglutethimide, and immunotherapy. Patients all showed disease progression after initial response to treatment. During the study, all 14 patients received oral AS2-1 in doses ranging from 97 to 130 mg/kg daily and DES in doses ranging from 0.01 to 0.02 mg/kg daily. Patients exhibited few significant side effects.
Overall, there were two complete remissions, three partial remissions, seven cases of stable disease, and two cases of disease progression. All patients were known to be alive 2 years after the beginning of the study. The two patients who showed disease progression discontinued AS2-1 treatment. The use of DES in conjunction with AS2-1 is a confounding factor in interpreting any results of tumor response.