Results of Phase II Clinical Studies with Ukrain
A. LOHNINGER, J. MUSIANOWYC, F. JUDMAIER, D. MANFREDA, P. SPÄNGLER, H. ALBRECHT, J. HOFFMANN, and D. MEJER*
Second Department of Obstetrics and Gynecology. Vienna
Medical School. Spitalgasse 23.1090 Vienna. Austria;
44 rue Jeanne d'Arc, Paris. Frances;
Allgem. Öffentl. Krankenhaus des Landes Kärnten in Klagenfurt. and HERA, Löblichgasse 4. A1090 Vienna. Austria;
Lukas Clinic. Brachmattstrasse 19, Arlesheim. Switzerland; and
Clinic for After Cancer Treatment. Welpeloweg 4, 75S6 BJ Overdinkel. The Netherlands*
Ukrain, tris(2-((5bS-(5ba,6b,12ba)]-5b,6,7,12b,13,14-hexahydro-13-methyl[1,3]benzodioxolo[5,6-c]-1,3-dioxolo[4,5-i]phenanthri-dinium-6-o)-ethaneaminyl)phosphinesulfide-6HCl, is widely used in oncological therapy, especially in cases where other therapy modalities show little or no successes. It is a semisynthetic compound, deriving from alkaloids of Chelidonium majus L. and thiophosphoric acid. Pharmacological, preclinical, toxicological, and clinical studies have defined the mechanisms of action of Ukrain on cancer cells to be directly inhibitory (6) or mediated by elements of the immunological apparatus (4), malignotoxicity (1), while on normal cells it is without recognizable effects in doses far beyond the therapeutic range, except on cell populations of the erythropoietic system, where it may modulate and stimulate the T4, NK, and macrophage populations and inhibit the T suppressors (T8). Ukrain has no mutagenic, teratogenic, or carcinogenic properties whatsoever, is extremely well tolerated, has analgesic effects, and may ameliorate the general status (2, 3). It has proven to be valuable in induction therapy prior to surgical treatment (encapsulation and decreasing of the tumor and metastases mass) and to ameliorate the effects of chemo- and/or radiation therapy (5). Beyond some reversible feeble objective (fever) and subjective (itching and nausea) side effects which may be explained by interference of the tumor degradation products with the whole organism, no adverse reactions are seen.
The aim of the following study was to determine the influence of Ukrain on outcome of the disease, including the changes of the specific pathological parameters and general considerations, in 103 cancer patients in later stages of disease.