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  • 11
    Electronic Resource
    Electronic Resource
    Amsterdam : Elsevier
    Journal of Steroid Biochemistry 28 (1987), S. 111 
    ISSN: 0022-4731
    Source: Elsevier Journal Backfiles on ScienceDirect 1907 - 2002
    Topics: Biology , Chemistry and Pharmacology
    Type of Medium: Electronic Resource
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  • 12
    ISSN: 1432-0851
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary A phase I study with recombinant human tumor necrosis factor α (rhuTNF-α; Knoll AG, Ludwigshafen, FRG) in patients with advanced malignant disease was undertaken to evaluate drug toxicity (organ specifity, time course, predictability, reversibility, maximal tolerated dose), effectiveness, antigenicity and pharmacokinetics. TNF was administered as a test dose followed by daily i.v. infusions for 5 days, every 3 weeks (single i.v. infusion lasting 10 min, TNF dissolved in 50 ml 5% human albumin). Dosage was increased in groups of 3 or 4 patients from 0.04 mg/m2 to 0.28 mg/m2. A total of 19 patients with different cancers, including seven large-bowel carcinomas, three chronic myelogenous leukemias, three hypernephromas, two small-cell lung cancers, one malignant melanoma, one malignant lymphoma, one rhabdomyosarcoma and one fibrosarcoma were treated. Major side-effects were chills and fever (maximum 40.4°C, median 38.7°C, 19/19), headache (12/19), nausea and vomiting (12/19) and pronounced (〉20%) hypotension (4/19). Acute side-effects could be diminished by paracetamol or indomethacin pretreatment, and with one possible exception no tachyphylaxis to TNF was noted. Mild renal toxicity was seen during TNF treatment. Pharmacokinetic studies showed a serum half-life (t 1/2) ranging from 11 min to 17 min for doses from 0.04 mg/m2 to 0.16 mg/m2 and prolonged clearance with t 1/2 ranging from 54 min to 70 min in the 0.20–0.28 mg/m2 dose range. No objective antitumor effects were observed in this phase I study.
    Type of Medium: Electronic Resource
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  • 13
    Electronic Resource
    Electronic Resource
    Springer
    Cancer chemotherapy and pharmacology 28 (1991), S. 59-62 
    ISSN: 1432-0843
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary In a phase I study, a range of doses of etoposide (200–370 mg/m2 given i. v. daily on 3 consecutive days) were evaluated for tolerance and response as first-line treatment in 26 patients with non-small-cell lung cancer. The dose-limiting toxicity was myelosuppression, especially leukopenia. At dose levels of 350 and 370 mg/m2 ctoposide per day, leukopenia of WHO grade 4 occurred in two and one of seven patients, respectively. No thrombocytopenia of this degree was observed. Myelosuppression was quickly reversible and noncumulative. Apart from alopecia, nonhematologic organ toxicities above WHO grade 2 were not seen. Toxicity analysis suggests that the recommended dose of single-agent etoposide for phase II studies in untreated patients is 330–370 mg/m2 given i. v. daily for 3 days. At the dose levels tested, 6 (23%) major responses could be induced. All responses were seen at a starting dose of 〉300 mg/m2 per day. The median duration of response was 4 months. The median survival for all patients was 8 months and that for responding patients was 15 months.
    Type of Medium: Electronic Resource
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  • 14
    Electronic Resource
    Electronic Resource
    Springer
    Journal of cancer research and clinical oncology 94 (1979), S. 325-331 
    ISSN: 1432-1335
    Keywords: Interstitial cell tumor of testis ; Metastases ; Case report ; Alkaline phosphatase ; Hormonal dysfunction ; Chemotherapy ; Metastasierender Leydig-Zell-Tumor des Hodens ; Fallbericht ; Alkalische Phosphatase ; Hormonelle Dysfunktion ; Chemotherapie
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Zusammenfassung Der metastasierende Leydig-Zell-Tumor des Hodens gehört zu den seltensten menschlichen Neoplasien. Bisher sind 18 Fälle beschrieben worden. Die Mehrzahl dieser Tumoren zeigt hormonelle Aktivitäten. Der von uns beobachtete maligne Leydig-Zell-Tumor weist neben einem ungewöhnlichen Hormonprofil zusätzlich ein Markerenzym — die alkalische Phosphatase — auf. Bei fehlender Radiosensibilität wurde auch mit neueren cytostatischen Substanzen kein Therapieerfolg erreicht. Weniger als 10% aller Leydig-Zell-Tumoren erfüllen die Kriterien der Malignität. Achtzehn Fallbeschreibungen der malignen Form liegen unseres Wissens bisher vor. Wir berichten über einen weiteren Patienten mit histologisch gesichertem Laydig-Zell-Tumor, den klinischen Verlauf, die therapeutischen Erfahrungen mit neueren cytostatischen Substanzen sowie die Besonderheit eines Enzym-Markers.
    Notes: Summary Metastatic interstitial cell tumor of the testis is one of the rarest human neoplasms. This is the nineteenth case to be reported. While most of these tumors are combined with hormonal dysfunction, the present tumor, apart from its uncommon hormonal profile, is remarkable because of its capacity of producing and secreting a marker enzyme, alkaline phosphatase. No response was seen after cytostatic therapy with new antineoplastic agents, such as a combination of adriamycin and cis-diamminedichlorideplatinum (II), and ifosfamide. Considering the lack of radiosensitivity, surgery is the primary modality of treatment.
    Type of Medium: Electronic Resource
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  • 15
    Electronic Resource
    Electronic Resource
    Springer
    Journal of cancer research and clinical oncology 97 (1980), S. 81-86 
    ISSN: 1432-1335
    Keywords: Chemotherapie ; Antiemese ; Levomepromazin ; Chemotherapy ; Antiemetics ; Levomepromacine
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary The antiemetic quality of the orally administered phenothiazine derivative levomepromacine was studied under clinical conditions in cancer patients receiving either cisplatin alone, ifosfamide alone or adriamycincontaining combinations. Seventy of 113 evaluable patients (62%)-all refractory to conventional antiemetics-were fully protected from nausea and vomiting when levomepromacine (2×8–15 mg) was administered in two steps (12 h and 1 h before the cytotoxic agents). Another 34% of all patients showed considerable improvement with respect to gastrointestinal side effects. The most pronounced effect with levomepromacine was seen in patients treated with a 20 mg/m2 daily×5 schedule of cisplatin but complete or partial relief was also seen with high single cisplatin doses of 50–100 mg/m2. In addition, the antiemetic showed effectiveness against nausea and vomiting induced by other agents, such as adriamycin or isofosfamide. Although a final evaluation of the antiemetic effect of levomepromacine will have to be based on a double-blind study, these initial observations have already been of great value for many patients.
    Notes: Zusammenfassung Unter stationär-klinischen Bedingungen wurde die zufällig beobactete antiemetische Qualität des oral angewandten Phenothiazinderivats Levomepromazin bei Tumorpatienten untersucht, welche entweder mit Cisplatin, Iphosphamid oder Adriamycin-haltigen Kombinationen behandelt wurden. Alle auswertbaren Patienten waren refraktät genenüber konventionellen Antiemetika. Bei einer Gesamtzahl von 113 Patienten konnte in insgesamt 70 Fällen (62%) ein voller Schutz vor Übelkeit und Erbrechen durch eine zweimalige Anwendung von Levomepromazin in einer Dosierung von 8–15 mg je 12 Std und 1 Std vor Beginn der Chemotherapie bewirkt werden. Bei weiteren 34% aller Patienten war eine deutliche subjektive Besserung hinsichtlich der gastrointestinalen Nebenwirkungen zu verzeichnen. Am ausgeprägtesten war der antiemetische Effekt von Levomepromazin bei Patienten unter konventioneller Cisplatin-Therapie (20 mg/m2 täglich×5), jedoch konnte eine eindeutige Wirkung auch bei hohen Cisplatindosen bis 100 mg/m2, welche normalerweise zusehr starken Nebenerscheinungen führten, nachgewiesen werden. Darüber hinaus war der antiemetische Effekt von Levomepromazin auch gegen Übelkeit und Erbrechen im Zusammenhang mit Adriamycin oder Iphosphamid wirkungsvoll. Obwohl eine endgültige Beurteilung des antiemetischen Effekts von Levomepromazin erst auf der Basis einer Doppelblindstudie möglich sein wird, was das Medikament bereits bei zahlreichen Patienten von großem Wert für die praktische Durchführung einer effektiven Zytostatikathepie.
    Type of Medium: Electronic Resource
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  • 16
    Electronic Resource
    Electronic Resource
    Springer
    Journal of cancer research and clinical oncology 107 (1984), S. 57-60 
    ISSN: 1432-1335
    Keywords: Cisplatin ; Phase II study ; Solid tumors
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Seventy-three evaluable patients with advanced measurable solid tumors were given cisdichlorodiammineplatinum (II) (DDP) at a dose of 20 mg/M2 IV for 1–5 days every 3 weeks, and 19 patients who failed on this low dose DDP protocol received a single high dose of 100 mg/M2 IV once every 3 weeks. Forty-six patients had received prior chemotherapy, and 29 patients were untreated. Results included four complete responses (5.5%) in malignant melanoma, spindle-cell sarcoma, adrenal carcinoma, and bladder carcinoma lasting 2 to 4 months. In 21 patients (28.8%), partial responses were achieved. Twenty-two patients (30.1%) showed stable disease and 26 (35.6%) had tumor progression. A response rate of 25% (4/16 patients) was found for malignant melanoma, 45.5% (5/11) for nonsmall-cell lung cancer, and 35.3% (6/17) for sarcomas of various types. One patient with teratocarcinoma, who relapsed on low-dose DDP, had another partial remission for 4 months after high-dose therapy. Toxicity was most commonly seen with gastrointestinal side effects and myelosuppression. Cumulative nephrotoxicity was prevented by prehydration and/or treatment with furosemide or mannitol.
    Type of Medium: Electronic Resource
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  • 17
    ISSN: 1432-1262
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Sixty-five patients with advanced colorectal cancer were randomised to one of two schedules of recombinant alpha-2 interferon (IFN). In the first study, 36 patients received single-agent IFN, either 50×106 U/m2 intravenously on 5 consecutive days every 4 weeks, or 20×106 U/m2 subcutaneously three times per week. No tumour responses were seen and toxicity was unacceptable. In the second study, 29 patients received IFN in two similar schedules, but the dose of IFN was reduced to 20×106 U/m2 per day in the intravenous arm and to 5×106 U/m2 per day in the subcutaneous arm. In addition these patients were administered intravenous 5-Fluorouracil (5-FU), 250–500 mg/m2 per day on the first 5 days of each 4-weekly cycle. Although the toxicity of this second study was tolerable, only one short-lived partial remission was observed. Alpha-2 interferon, alone or in combination with 5-FU, is ineffective in advanced colorectal cancer.
    Type of Medium: Electronic Resource
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  • 18
    Electronic Resource
    Electronic Resource
    Springer
    Journal of cancer research and clinical oncology 105 (1983), S. 162-165 
    ISSN: 1432-1335
    Keywords: Aclacinomycin A ; Phase II study ; Refractory neoplasms
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Aclacinomycin A (ACM) is a new anthracycline antibiotic with a reduced cardiac toxicity in animal models. A phase II study was performed in a total of 25 patients, 23 of whom are evaluable for response. All suffered from recurrent and advanced tumors. Pretreatment consisted of at least four different chemotherapeutic agents (range: 4–9). Lung cancer patients (3/9) were irradiated to the mediastinum. Eighteen patients were pretreated with doxo- or daunomycin. The dose for solid tumors was 2–3 mg/kg given on 3 consecutive days every 3 weeks. Leukemia patients received a daily dose of 20 mg/m2, and standard response criteria were used. Marked reductions of leukocyte counts were achieved in leukemia patients. The overall response rate was about 15% in solid tumors, but major objective responses (CR+PR) have not been observed. Myelosuppression was commonly moderate in solid tumor patients, nausea and vomiting were rare, and alopecia was not induced. Cumulative cardiotoxicity was not evaluated in this trial. Treatment with ACM requires further investigation in acute leukemias and solid tumors, not pretreated with anthracycline antibiotics.
    Type of Medium: Electronic Resource
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  • 19
    Electronic Resource
    Electronic Resource
    Springer
    Journal of cancer research and clinical oncology 107 (1984), S. 38-41 
    ISSN: 1432-1335
    Keywords: 4′-Epi-doxorubicin ; Phase-II trial ; Refractory neoplasms
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary 4′-Epi-doxorubicin is a new anthracycline analog with reduced cardiac toxicity in animal studies. A phase-II study was performed in 17 patients predominantly with non-small-cell lung cancer. All suffered from recurrent or advanced tumors and 7 of 16 evaluable patients had been pretreated with an alternative chemotherapy. 4′-Epi-doxorubicin was applied at a dose of 75 mg/m2 every 3–4 weeks. The median total dose was 280 mg (range: 130–250 mg). Only one patient with epidermoid lung cancer (overall response rate: 6%) showed a minor response and stable disease was observed in six other patients with bronchogenic carcinoma. Myelosuppression was rare and moderate: Leukocytopenia of less than 2,000/mm3 occurred in 25% of patients and thrombocytopenia of less than 100,000/mm3 in 8% of patients. The frequency of alopecia and gastrointestinal side effects was 88% and 80%, respectively. Persistent electrocardiographic alterations were recorded in 2 of 14 (14%) patients. One of four patients revealed a marked reduction of left ventricular ejection fraction in radionuclide cardiography. It is concluded that 4′-epi-doxorubicin is not superior to adriamycin in this low-prospect treatment area, but studies with increased doses appear necessary in adriamycin-sensitive tumors because of recent reports from phase-III trials showing reduced cardiac and gastrointestinal toxicity with 4′-epi-doxorubicin in comparison with adriamycin.
    Type of Medium: Electronic Resource
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  • 20
    ISSN: 1432-1440
    Keywords: Small cell lung cancer ; Sequential chemotherapy ; Thoracic irradiation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary To study the potential benefit of sequential chemotherapy in inoperable small cell lung cancer (SCLC), from 1982 to 1986 ninety-one patients with histologically proven and previously untreated SCLC (median age: 53 years; median Karnofsky status: 80%) were randomly assigned to an initial therapy with adriamycin (since 1984 epirubicin), cyclophosphamide, vincristine (ACO resp. EPICO) or etoposide/cisplatin (VP16/DDP). Treatment courses were repeated every 3 weeks for a total of ≤6 courses with a crossover after a maximum of 3 cycles of either regimen. Limited disease (LD) patients with bronchoscopical, computertomographical and (re-) mediastinoscopical complete remission (CR) randomly received either a thoracic irradiation with 40 Gy or observation only. Overall, 60 out of 85 evaluable patients achieved an objective remission. A CR was observed in 24/51 patients (47%) with limited disease, and in 8/34 patients (24%) with extensive disease. Both, ACO (EPICO) and VP16/DDP were equally effective as initial and second-line therapy. Moreover, after failure to the initial therapy an objective remission could be achieved in 13% of the patients following the alternative second line combination. In 28% of LD patients with an otherwise complete remission residual tumor was detected by (re-) mediastinoscopy. Median survival times were 14 (CR: 16) months in LD patients and 10 (CR: 15) months in ED patients. At present, median survival is significantly improved in irradiated versus non-irradiated LD patients (25 vs. 13 months, p〈0.04). The remission rates and median survival times observed in this study are comparable to those of a historical control group treated with ACO plus radiotherapy alone.
    Type of Medium: Electronic Resource
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