Twenty-one patients with advanced cancer or leukemia were treated with antineoplaston A and followed for up to nine months. Dosage by intravenous, intramuscular, subcutaneous, rectal, intrapleural, intravesical and/or topical administration ranged from 0.6 to 33 U/m2/24 h. Treatment was well tolerated, although side effects included fever of short duration and elevation of platelet and white blood count. In 18 cases some degree of clinical improvement was observed. Complete remission occurred in 4 cases. More than 50% remission occurred in 4 other cases which, along with another 6 cases, are continuing the treatment with high doses of antineoplaston A and show a continuing regression of the tumors although not yet achieving the criteria for complete remission; 2 of these 6 cases seem unlikely to achieve remission. Two patients temporarily discontinued treatment. During treatment, 5 patients expired; in 2 of them, however, was seen significant regression of the neoplastic process. The deaths were not due to cancer or to any toxicity incurred by the treatment.