It was noted that several of the patients received antineoplaston treatment shortly after taking radiation therapy, and the question of the possibility of a confounding effect of residual continued improvement following radiotherapy on evaluating response to antineoplastons was raised. However, complete resolution of both postradiation edema and tumor enhancement was demonstrated on CT scans in several cases, therefore negating the possible problem of differentiating between progression of tumor and postradiation edema. In discussion, it was clarified that the proposed Phase II trials would utilize the combination of antineoplastons A10 and AS2-l, without any other therapy. No problems were foreseen with filing the INDA on the pharmaceutical preparation provided by Dr. Burzynski. The primary rationale for using a mixture of the two antineoplastons in the proposed trials is to duplicate exactly the regimen used in the studies at the Burzynski Institute .
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