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9A SEMISYNTHETIC COMPOUND FROM THE ALKALOIDS OF CHELIDONIUM MAJUS L. AND THIOPHOSPHORIC ACID TRIAZIRIDIDE NSC631570 AND ITS INFLUENCE ON CHILDREN
(A REVIEW OF CASE REPORTS)
Romanchuk V.O.
Graduate Student Lviv National Ivan Franko University Henerala Chuprynky Street, 49, 79044, Lviv, Ukraine https://orcid.org/0000-0003-1594-3995
Abstract
The article deals with the theme of the treatment of cancer diseases nowadays. The author describes the patient cases of adults as well as of children who have already exhausted all conventional methods of therapy after what they began treatment with the semisynthetic compound from the alkaloids of Chelidonium Majus L. and thiophos-phoric acid triaziridide named NSC631570 (Ukrain). The author makes a detailed review of clinical reports.
Keywords: cancer, disease, patients, NSC631570, children, diagnosis, treatment, conventional method, brain tumor, Xeroderma pigmentosum, astrocytoma, patient cases, clinical reports, WHO statistics.
In 2000 Dr. Burkhard Aschhoff ("Villa Medica Clinic", Edenkoben) from Germany presented results of the treatment of203 patients with various cancer diseases. These advanced-stage cancer patients with different types of cancer had already exhausted all other forms of the conventional therapy and after that were treated with the anti-cancer preparation NSC631570 (Ukrain) in the period between August 1997 and the end of 1999 at the „Villa Medica Clinic" in Germany. 76 patients (37.4%) were simuitaneousiy treated with regional deep hyperthermia. Patients also received complementary oncological treatment with seien, Cimetidine, thyme extract and vitamin A. The results of therapy were surprising. 41 patients (20.2%) achieved total remission, 122 (60.1%) partial remission and only 40 (19.7%) did not respond to treatment. (2)
NSC631570 (Ukrain) is a semisynthetic compound from the alkaloids of Chelidonium majus L. and thio-phosphoric acid triaziridide, which has already been shown to have considerable promise in the treatment of a variety of oncological diseases (14, 6, 11, 3, 13). The mechanism of action of this preparation has not yet been elucidated, but nevertheless it has demonstrated efficacy only against cancer cells while leaving healthy cells undamaged (4).
In vitro tests at the National Cancer Institute (Be-thesda, USA) showed that NSC631570 is effective and malignocytolytic against all human cancer cell lines tested (8). NSC631570 has been shown to induce apop-tosis (programmed cell death) in malignant cells (5).
NSC631570 corrects the immune response of patients, especially T-cell mediated response as well as enhanced cell-mediated cytotoxicity with an increase in the T-lymphocyte count and normalization of the T-helper/-suppressor ratio (9).
Patients received NSC631570 at a dose of 0.3 mg/kg b.w., 3 times per week for 3 weeks. The preparation was administered with a standardized 250 ml 5% glucose infusion solution with the addition of vitamin C (Pascoe, Giessen, Germany) at 0.3 g/kg b.w. 76 patients also received regional deep hyperthermia in which tumor tissue was heated to a temperature of >42.5 °C. After immune phenotyping patients received
accompanying complementary oncological treatment with seien (Biosyn, Fellbach, Germany), Cimetidin (ct-Arzneimittel, Berlin, Germany), thyme extract (Dr. Aschoff, Edenkoben, Germany) and vitamin A (Je-napharm, Jena, Germany).
203 patients had a mean age of 46.3 years (22 months to 74 years). There were 14 children among them below the age of 16 (8 girls and 6 boys) and 189 adults (107 women and 82 men). 76 (37.4%) were simultaneously treated with regional deep hyperthermia in treatment cycles of 3 weeks with a 3-4 week pause between cycles. Patients underwent 1-15 cycles (average 2.6 cycles).
NSC631570 was generally well tolerated. Typical adverse effects were temperature increases of up to 2-3 °C, feelings of warmth, stabbing pains, itching and tingling sensations at the sites of tumors or metastases. Some patients reported feelings of nausea after the first NSC631570 injection but not after subsequent injections. 3 patients presented skin rash. All these adverse effects disappeared spontaneously and none required medication or additional therapy. Interruption of NSC631570 therapy as a result of adverse effects was not indicated in any of the patients.
These adverse effects appeared in patients who responded to therapy and disappeared as the tumor mass became smaller. It can therefore be concluded that they were caused by the influence of tumor degradation products rather than by NSC631570 itself.
Immune phenotyping before and 3-5 days after each treatment cycle showed that on average the lymphocyte count increased by 122%, total T-lymphocytes by 87.2% and natural killer cells by 87.2%. Total CD4 lymphocytes increased by 113% and total activated CD4 lymphocytes by 98.2%.
Patients who responded to NSC631570 therapy showed an improvement in their general condition, with reduced pain, increased appetite, increased vitality, a more positive attitude and normalization of sleep patterns.
These results of NSC631570 therapy are outstanding, especially in view of the fact that these patients had exhausted all conventional forms of cancer therapy. The improvement in immune status brought about by
NSC631570 is also noteworthy. The greatest changes occurred in patients whose immune systems were most damaged. As immune levels returned within the normal range the influence of NSC631570 was reduced, leading to the conclusion that the drug is an immunocorrec-tor.
The results of the treatment were as follows: among adults there was a complete remission in 16.58% of cases, it was possible to achieve a partial remission in 62.57% of cases and for 20.86% of patients did not respond to treatment. At the same time very interesting were the comparative results of the treatment of children: complete remission 62.5%, partial remission 31.25% and no influence 6.25%.
In accordance with the WHO statistics 400 000 children from 0 up to 19 years receive diagnosis "cancer disease" all over the world each year. (https://www.who.int/news-room/fact-sheets/detail/cancer-in-children) 20 % of them have relapse so it is impossible to help them.
To show the potential and influence of this medical preparation without any side effects on the children we present 6 patients cases which are documented and listed below.
1. A medical story of the patients Daniel B. suffering from xeroderma pigmentosum. Daniel was a case of Xeroderma pigmentosum, which was confirmed by genetic examinations at the University of Tuebingen (Germany). As Daniel was between the ages of 6 and 16 a total of 56 operations were necessary, especially on the face. He had already had all forms of
skin cancer from the relatively harmless basal cell carcinoma to malignant melanoma. It should be noted that the life expectancy of these patients is only 16 years of age and Daniel, who is in the meantime over 36 years-old, has fortunately lived considerably longer. Dr. Burkhardt Aschhoff rom Germany began his treatment on 27.08.2001 and observed that from the beginning of treatment basically no further tumours formed. Over the last 11 years on average one smaller excision per year was performed, which were found to be semi-malignant tumours. Only in 2010 Dr. Aschhoff removed two small tumours, which were malignant melanomas, from the skin in the region of the right knee. An examination of the sentinel lymph node showed that no metastases were present and no relapses or lymphomas have been observed now. The tests during treatment were first carried out at Fachklinik Hornheide and later at the University of Tuebingen (both in Germany). It has been demonstrated that this treatment of the young man has been highly effective in preventing further malignant tumors as well as preventing the spread of metastases. No side-effects have yet appeared as a result of treatment with NSC631570. The regular laboratory tests carried out during treatment showed no changes in the blood count nor changes in liver, kidney, pancreas and other metabolic levels. I was also able to demonstrate and confirm this with other documented case reports. The young patient works regularly, primarily on the night shift. (http://www.ukrin.com/docs/daniel-b-english.pdf, 1)
Fig. 1
Fig. 2
Fig. 3
Fig. 4
2. Patient S.S., an 8 years old boy, was presented with an ulcering lesion of the nose. As he was 10 months old, xeroderma pigmentosum was diagnosed. Until the age of three years the number of skin lesions increased considerably. In May 2002 skin cancer (squamous cell carcinoma) at the nose was diagnosed, T4NXM0, histologically verified. From May till June 2002 three cycles of chemotherapy were administered (cyclophosphamide, vincristine, and vinblastine). The therapy failed and the tumors grew up. Clinical investi-
gation in April 2004 revealed deforming malignant
melanoma of the nose with invasion into the cartilage of nasal septum, measuring 3x3 cm. On 20 May 2004 the therapy with NSC631570 was started, 5 mg intravenously twice a week, up to a total dose of 85 mg. One month after the last administration of NSC631570 a complete regression of the tumor was revealed. The skin defect was partially replaced with connective tissue. Xeroderma skin lesions improved throughout the body. (https://ukrin.com/en/xeroderma, 10)
Fig. 5
Patient S.S. before the therapy with NSC631570. Deforming invasive malignant melanoma of the nose. April 2004
Fig. 6
Autofluorescence of NSC-631570 at the melanoma area under UV-light during the first intravenous injection. May 2004.
Fig. 7
Patient S.S. in December 2004. Complete regression of the tumor, with connective tissue substitution.
The 3 years-old Stefan Dan with the diagnosis of generalised lymphangiomatosis was sent home by doctors in 1995 as having exhausted all forms of therapy. (http://www.ukrin.com/en/obstructive-tactics-consequences ) From the medical records of the Uni-versitaetstsklinik fuer Kinderheilkunde, Vienna (Austria): "After consultation with our oncologist tumour progression cannot be counteracted either by chemotherapy or radiotherapy. Surgery is also no longer possible so that further therapy can only be palliative".
Fig. 10
(https://ukrin.com/docs/zusammenfassung-kg-dan.pdf) After that the treatment with NSC631570 has begun and an unexpected improvement occurred. The next cource with the NSC631570 began in September 2000 and the condition of the child gradually improved. (https://ukrin.com/docs/zusammenfassung-kg-dan.pdf) Stefan is now 29 years old. He is intelligent, can read, write and paint and plays the piano.
Fig. 11
4) A 13-year-old girl Mariana Katic with tuberous sclerosis and subependymal giant cell astrocytomas was treated with NSC631570. Although neurosurgical operations were also performed, complete tumor excision was not possible. In view of the young age of the patient and the development of the clinical picture of hypertension in CSF pathways, the therapeutic approaches in this case were limited. While a number of symptomatic neurosurgical operations were performed, progressive growth of intracranial tumors made the prognosis unclear. NSC631570 administration led to a great improvement in clinical status and also to partial regression of astrocytoma growth, which can be observed to date. Mrs. Katic has given birth to a healthy son. (https://ukrin.com/docs/uk7nowicki.pdf , 7)
5) An 8-years-old girl was twice operated for a Grade I astrocytoma of the chiasma. First the girl was operated on 13th December 1989. "Beginning 1991 a definite recurrence of the right-sided tumor could be demonstrated and the right eye was blind". The second operation was implemented on 25th April 1991. "Hemianopsia on the left visual field developed; blindness at right. No changes since October 1993; (...)". Treatment with Ukrain was initiated. It started on 21th April 1994 and continued until 27th March 1995. After treatment with Ukrain: "Patient feels well and is doing well at school. (...) To date therapy with Ukrain in this patient is a complete success and calls for further clinical studies". (http://www.ukrin.com/docs/steinacker_1996_2.pdf , 12)
6) Dr. Frank Daudert from Bayern (Germany) reported on his therapeutic success with a girl diagnosed with a brain tumor. "After 14 days I was astounded to see that her symptoms of paralysis were declining, the oblique position of the head had returned to normal and the child was again able to swallow. After a further 14 days the child once more attended the UNI-Klinik in Munich to check if the tumor was operable. During the course of further examinations, it was found that the tumor had in fact reduced in size and the tumor was operable. The operation was carried out successfully and suffered no relapse later". (http://www.ukrin.com/de/node/308)
All these facts mentioned above should compel to think seriously about the potential of the medical anticancer preparation under the title NSC631570 especially for young patients, because all these children mentioned above were in a hopeless condition from a medical point of view.
References
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