More results from Carbon 60 Hydrated Fullerenes and Colon/Rectal Cancer -Observational Case Study from conference in Toronto 2000
Symposium "Fullerenes in Biology and Medicine" of 197th Meeting of the American ECS (May 14-18, 2000, Toronto, Ontario, Canada). Abs# 700 (2 p)
http://www.electroch...7/pdfs/0700.pdfFirst clinical case of treatment of patient (volunteer) with rectal adenocarcinoma by hydrated C60 fullerenes: natural course of the disease or non-specific anticancer activity? G.V. Andrievsky, A.V. Zhmuro, L.V. Zabobonina*.
Institute for Therapy of AMS of Ukraine, Department of Mass Spectrometry, 2-a, Postysheva st.,310039, Kharkov, Ukraine. E-mail: yard@kharkov.ua *- Institute of Medical Radiology of MH of Ukraine, Department of Radiology, 82, Pushkinskaya st., 310002, Kharkov, Ukraine
INTRODUCTION Subject of the report is description of more than 3.5-year-long observation of patient with rectal adenocarcinoma that was treated by C60FWS, namely the molecular–colloid aqueous solutions, containing both single fullerene molecules and their fractal clusters in a hydrated state - [C60@(H2O)m]n [1-4; +Ukrainian patent applications 99084515 (06.08.99) and 99095066 (13.09.99)]. Possibility of administration of hydrated C60 fullerenes in supersmall (homeopathic) doses had been based on the following: - evidences of significant antioxidative, membrane-stabilizing, antiinflammatory and immunomodulative effects of hydrated C60 fullerenes in treatment of experimental pathology [5-7]; - facts on extremely (negligible) low toxicity of fullerenes (for the doses used) [8,9], and absence of mutagenic [10] and carcinogenic properties [11] of these substances; - data on presence of fullerenes in natural sources (e.g. Shungite rocks [12,13]) and on probable participation of supersmall doses of fullerenes in medicinal effects, when people drink the Marcial water (water, that has passed through the Shungite rocks[14]) or take an activated charcoal [15]; - data on possibility of usage of fullerenes as plasmosorbents in treatment of atherosclerosis [16].
RESULTS AND DISCUSSION The patient V.G., 71 years old, in May 1996 had been diagnosed to have rectal adenocarcinoma (T3NxMx, ampular region). In June 1998 the diagnosis had been confirmed morphologically during laparoscopy (T3NxM1P3, stage 4, clinical group IV, liver Mts). In May 1996 the patient refused to receive surgical treatment and, in June 1998, from anticancer chemotherapy. No specific therapy had been administered, except of the course of radiation (-therapy) in a total doze of 61,4 Gy during 07-09.1998 and local symptomatic treatment. As mentioned earlier, the patient voluntarily refused to receive specific anticancer treatment and, from May 1996, received hydrated C60 fullerenes, per os, in supersmall (homeopathic) doses, in a regular way. The total dose of C60 for 3.5 years of treatment has not exceeded 2 mg. At present the main clinical data are the following: the patient is stable; intestinal function is preserved; the patient feel himself quite satisfactorily and is able to work; has no specific complaints; constipation is controlled by laxatives. Two times the patient had been treated from paraproctitis (27.09.99 and 17.11.99). At present, the tumor size measured by means rectoromanoscopy did not change. Regular (once a year, since 1998) computer tomography do not reveal new metastatic foci. Restoration of blood hemoglobin level (Hb, g/L) in the patient are given in Fig.1. It is well known that natural course of the oncologic disease, as a strong rule, leads to serious decrease in Hb level, and we observed the opposite direction of changes. Note that the administration of hydrated C60 fullerenes at the period of -therapy was connected with quick restoration of Hb level. Although, in this clinical situation, there is not enough data for understanding of cause-effect relationships, one can hypothesize that antioxidative, membrane-stabilizing and radioprotective effects of hydrated fullerenes could facilitate to restoration of erythropoesis and protection of liver function.
We also has data on some other cases of hydrated C60 fullerenes’ efficacy in patients-volunteers with nontreatable (not subject to surgery) pancreatic carcinoma, lung cancer, multiple myeloma. The criteria of treatment efficacy (meant for all these cases) were: clinical signs and symptoms; tumor size and/or growth rate; life expectancy; Hb blood level. In these cases there had been registered «smoothing» of symptoms, clinically significant analgetic and antiinflammatory action, tendency to normalization of blood Hb level and ESR (the erythrocytes sedimentation rate).
Our results, from the point of view of generally accepted international standards of drug testing (GMP, GLP, ICH GCP), can not be viewed as (and do not pretend to be) a well-based scientific evidence of specific anticancer efficacy of hydrated fullerenes. The obvious limitations of this clinical report are connected with insufficient (both clinically and statistically) number of cases described; the fact that the natural course of the disease, as well as placebo effect, could be responsible for the changes observed. But the facts described permit to test hypotheses on these effects during experimental pharmacological studies and, later on, in clinical drug trials in oncology, may be also as an additional therapy. As the actions of hydrated C60 fullerenes are seen when using supersmall doses of the substance, the initial approaches for clinical investigation of C60FWS may be similar to those in development of homeopathic medicines. ACKNOWLEDGMENTS The authors thank Dr. R.O. Loutfy, President of MER Corporation (Tuscon, AZ, USA), for kindly providing of fullerene samples.
REFERENCES 1. G.V. Andrievsky, M.V. Kosevich, O.M. Vovk, V.S. Shelkovsky and L.A.Vashchenko. ON THE PRODUCTION OF AN AQUEOUS COLLOIDAL SOLUTION OF FULLERENES. J.Chem.Soc., Chem. Commun., 12, 1281 (1995). 2. G.V. Andrievsky, M.V. Kosevich, O.M. Vovk, V.S. Shelkovsky and L.A. Vashchenko. ARE FULLERENES SOLUBLE IN WATER? in: Chemistry and Physics of Fullerenes and Related Materials/1995, R.S.Ruoff and K.M.Kadish, Editors, PV 95-10, p.1591, The Electrochemical Society Proceedings Series, Pennington, NJ (1995). 3. G.V. Andrievsky, V.K. Klochkov, E.L. Karyakina and N.O. Mchedlov-Petrossyan. STUDIES OF AQUEOUS COLLOIDAL SOLUTIONS OF FULLERENE C60 BY ELECTRON MICROSCOPY. Chem.Phys.Lett., 300, 392 (1999). 4. G. V. Andrievsky, V. K. Klochkov and L. I. Derevyanchenko. FWS - MOLECULAR–COLLOID SYSTEMS OF HYDRATED FULLERENES AND THEIR FRACTAL CLUSTERS IN WATER SOLUTIONS. Book of Abstracts, 195-th Meeting of The Electrochemical Society ( May 2-6, 1999, Seattle, Washington) Abs# 710. 5. G. V. Andrievsky, A. D. Roslyakov and V. K. Klochkov. MOLECULAR–COLLOID SYSTEMS OF FULLERENES IN WATER AS PROTOTYPES OF THE NEW CLASS OF PHARMACEUTICALS. Ibid., Abs# 689. 6. A.D. Roslyakov, G.V. Andrievsky, A.Yu. Petrenko and L.T. Malaya. CYTOTOXIC AND ANTIOXYDANT PROPERTIES OF WATER SOLUTIONS OF THE NATIVE FULLERENES ON IN VITRO MODELS. Zh.Akad.Med.Nauk Ukrainy (Russ.), 5, 338 (1999). 7. A.D. Roslyakov, G.V. Andrievsky and L.T. Malaya. INTERACTION OF THE HYDRATED FULLERENE С60 WITH PLASMATIC MEMBRANE OF RED BLOOD CELLS. Book of Abstracts of The 4 th Biennial International Workshop in Russia "Fullernes and Atomic Clusters" (IWFAC'99, October 4 - 8, 1999, St. Petersburg, Russia) p.307. 8. L.A Mukovsky, P.P Iakoutseni, Yu.A. Lybimov G.S. Stroykova and L.S. Salova. THE TOXICOLOGICAL CHARACTERISTICS OF FULLERENES. Book of Abstracts of The Second International Workshop in Russia "Fullerenes and Atomic Clasters" (June 1924, 1995, St.Petersburg) p. 173. 9. A.W Jensen., S.R. Wilson and D.I. Schuster. BIOLOGICAL APPLICATIONS OF FULLERENES - A REVIW. Biorg. Med. Chem. 4, 767 (1996). 10. L.P Zakharenko, I.K. Zakharov, S.N. Lunegov and A.A. Nikiforov. DEMONSTRATION OF THE ABSENCE OF GENOTOXICITY OF FULLERENE C60 USING THE SOMATIC MOSAIC METHOD. Dokl.Akad.Nauk (Russ). 335, 261 (1994). 11. M.A. Nelson, F.E. Domann, G.T. Bowden S.B. Hooser; Q. Fernando; and D.E. Carter. EFFECTS OF ACUTE AND SUBCHRONIC EXPOSURE OF TOPICALLY APPLIED FULLERENE EXTRACTS ON THE MOUSE SKIN. Toxicol. Ind. Health. 9, 623 (1993). 12. S.V. Kholodkevich, A.V. Bekrenev, V.K. Donchenko, V.I. Domoroschenkov, O.I. Kon'kov, V.V. Poborchiy, E.I. Terukov, I.N. Trapeznikova. ISOLATION OF NATIVE FULLERENES FROM SHUNGITES OF KARELIYA. Dokl.Akad.Nauk. (Russ), 330, 340 (1993). 13. N.N. Rozhkova, G. V.Andrievsky, L.I. Derevyanchenko, V.K. Klochkov and E. Shulyakovskaya. FULLERENES IN SHUNGITE CARBON. EXTRACTION OF FULLERENES BY WATER-CONTAINING SOLVENTS. International Conference «Eurocarbon 2000», Berlin, July, 2000 (accepted). 14. S.A.Vishnevskiy, MEDICAL TERRAIN OF KARELIYA, p.57, GI KaASSR, Petrozavodsk (1957). 15. M. Shibuya, M. Kato, M. Ozawa, P.H. Fang, E.Хsawa. DETECTION OF BUCKMINSTERFULLERENE IN USUAL SOOTS AND COMMERCIAL CHARCOALS. Fullerenes Sci. and Technol., 7, 181 (1999). 16. V.M. Sedov Yu.M. Andozkaja, N.A. Podossenova, A.S. Kuznetsov. INVESTIGATION OF ADSORPTION PROPERTIES OF FULLERENE PLASMOSORBENT. ExConsilio, 2, 104 (1998).
Figure 1. Restoration of blood hemoglobin (Hb) level after laparoscopy (20.05.98) and course (30.06-27.07.98 and 11.08-02.09.98) of -therapy in the patient with rectal adenocarcinoma (T3NxM1P3) under treatment by supersmall doses of hydrated C60 fullerenes.
