Drugs Exp Clin Res. 1992;18 Suppl:45-50.
Clinical studies of Ukrain in terminal cancer patients (phase II).
Musianowycz J, Judmajer F, Manfreda D, Spängler P, Albrecht H, Hoffmann J, Meijer
Allgem. öffentl. Krankenhaus des Landes Kärnten in Klagenfurt, Austria.
Phase II of clinical studies was performed on 70 patients, ranging in age from 14
to 80 years, (27 male, 43 female) to determine the appropriate dose range for
Ukrain and the clarification of dose/response relationships, in order to provide
an optimal background for wider therapeutic trials. The following parameters were
studied: physiological (pulse, blood pressure, temperature); biochemical,
haematological and immunological. Electrolytes and trace elements were
investigated, as well as neopterin, tumour markers, immune complexes, non
specific blocking factors, development of tumours and metastases in quantitative
respects (by X-ray, CT, scintigrams and US). The patients' general conditions
were also assessed. Ukrain was given intramuscularly or intravenously every one,
two, three, four or five days, or according to other schemata, in the dose range
of 2.5, 5, 10, 15, 20 or 25 mg increasing (2.5 to 25 mg per injection),
decreasing (25 to 2.5 mg per injection) and stable (5, 10, 15, 20 or 25 mg per
injection). Duration of one course of therapy was between 10 days and 90 days.
Intervals between courses ranged from 7 days to 3 months. In order to find
dose/duration/interval/response-relationships, some cases were treated after
chemoradiotherapy, some as adjuvant therapy to chemo-radiotherapy and
alternatives such as iscador, and some as monotherapy. All patients were at
terminal stages of their disease.