CLINICAL STUDIES OF UKRAIN IN TERMINAL CANCER PATIENTS (PHASE II)

MUSIANOWYCZ J.,¹ JUDMAJER F., MANFREDA D.,² SPÄNGLER P.,³ ALBRECHT H., HOFFMANN J.,⁴ MEIJER D.⁵*

1) 44 rue Jeanne d'Arc, Paris, France.
2) Allgem. Öffentl. Krankenhaus des Landes Kärnten in Klagenfurt, Austria.
3) HERA, Löblichgasse 14, 1090 Vienna, Austria.
4) Lukas Clinic, Brachmattstrasse 19, Arlesheim, Switzerland.
5) Clinic for After Cancer Treatment, Welpeloweg 4, 7586 BJ, Overdinkel, The Netherlands.

* Author to whom correspondence should be addressed.
** (European Patent no. 0083600)

SUMMARY: 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 chemo-radiatiotherapy, 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.