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Human / Clinical Studies

    continued...

    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.[17] The use of DES in conjunction with AS2-1 is a confounding factor in interpreting any results of tumor response.

    Hepatocellular (liver) cancer

    A case report from Japan discussed two patients with advanced hepatocellular carcinoma who received antineoplaston A10 in addition to other treatments. Although both patients died—one from hemorrhagic pancreatic necroses and the other from hepatic failure brought on by esophageal varices—both appeared to tolerate A10 with few serious side effects. CT scans indicated that one patient exhibited inhibition of tumor growth and slight shrinkage of the tumor after oral administration and infusion of A10.[18]

    To date, no randomized controlled trials examining the use of antineoplastons in patients with cancer have been reported in the literature. Existing publications have taken the form of case reports or series, phase I clinical trials, and phase II clinical trials, conducted mainly by the developer and his associates. While these publications have reported on successful remissions with the use of antineoplastons, other investigators have been unable to duplicate these results [10] and suggest that interpreting effects of antineoplaston treatment in patients with recurrent gliomas may be confounded by pre-antineoplaston treatment as well as imaging artifacts.[11,14,16] Reports originating from Japan on the effect of antineoplaston treatment on brain and other types of tumors have been mixed, and in some Japanese studies the specific antineoplastons used are not named.[9] In many of the reported studies, several or all patients received concurrent or recent radiation therapy, chemotherapy, or both, confounding interpretability.

    Table 1 summarizes the dose ranges of antineoplastons used in the studies discussed above.

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