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  • 1
    Electronic Resource
    Electronic Resource
    Phase II trial of menogaril in adenocarcinoma of the pancreas (1991)
    Springer
    Investigational new drugs 9 (1991), S. 77-78 
    Details
    ISSN: 1573-0646
    Keywords: phase II ; menogaril ; pancreas ; cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00194550
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  • 2
    Electronic Resource
    Electronic Resource
    Hypersensitivity reactions to trimetrexate (1990)
    Springer
    Investigational new drugs 8 (1990), S. 211-214 
    Details
    ISSN: 1573-0646
    Keywords: trimetrexate ; hypersensitivity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Trimetrexate is a nonclassical antifol currently being tested for efficacy in cancer patients and as an antiparasitic agent against Pneumocystis carinii pneumonia in AIDS patients. We have now received the first reports of hypersensitivity reactions in Phase II cancer trials. Two types of reactions were noted. The most severe reaction, immediate hypotension with loss of consciousness, occurred in only one patient. Four other patients exhibited an immediate systemic effect with one or more of the following symptoms: facial flushing, fever, shaking, pruritus, bronchospasm, periorbital edema, and difficulty in swallowing. Immediate hypersensitivity should now be considered a known side effect of trimetrexate therapy, occurring in 〈 2% of patients.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00177263
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  • 3
    Electronic Resource
    Electronic Resource
    The effects of hip contact aberrations on stress patterns within the human femoral head (1980)
    Springer
    Annals of biomedical engineering 8 (1980), S. 75-92 
    Details
    ISSN: 1573-9686
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine , Technology
    Notes: Abstract A two-dimensional finite element model incorporating cancellous bone inhomogeneity is used to study femoral head stress alterations caused by changes from the usual articular contact patterns. The contact stress distributions, calculated from an earlier mathematical analysis by Greenwald and O'Connor (16), are found to influence not only the adjacent subchondral bone, but relatively distant parts of the head as well. Both abnormally large joint incongruity and abnormally low cartilage compliance cause load to shift away from the superior “weight-bearing” area, out toward the periphery of the contact region. As a consequence, transverse compressive stresses, which are of appreciable magnitude but which do not contribute to weight bearing, are built up throughout much of the superior and central portions of the femoral head. Most small changes in the overall cartilage thickness or in its thickness distribution, when considered in isolation from hip compliance changes, have only minor effects on the internal stress distribution. An important exception is cartilage thinning at the superior margin, which can result in abrupt longitudinal compressive stress concentrations. It is suggested that such alterations of the normal patterns of stress transmission may contribute to sclerosis or to the formation of osteophytes or cysts in the osteoarthritic hip.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02363172
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  • 4
    Electronic Resource
    Electronic Resource
    Phase II trial of gemcitabine (2,2′-difiuorodeoxycytidine) in patients with adenocarcinoma of the pancreas (1994)
    Springer
    Investigational new drugs 12 (1994), S. 29-34 
    Details
    ISSN: 1573-0646
    Keywords: pancreas ; adenocarcinoma ; gemcitabine ; 2,2′-difluorodeoxycytidme ; phase II
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Gemcitabine is a novel nucleoside analog which demonstrated a broad spectrum of preclinical acitivity in solid tumor models, and responses in patients with pancreas cancer during phase I evaluation. Patients with measurable adenocarcinoma of the pancreas who had received no previous chemotherapy were eligible for this multicenter phase II clinical trial. Gemcitabine 800 mg/m2 was administered intravenously weekly for 3 consecutive weeks, followed by one week rest, every 4 weeks. Forty-four patients entered the trial; 35 had at least 2 cycles of therapy. Partial response was observed in 5 patients (11%, estimated 95% confidence interval 2–20%), with a median duration of 13 months. All responding patients had stabilization or improvement in performance status. Fourteen patients had stable disease of 4 or more months. The median WBC nadir was 3.8 × 103/μl (range 1.6–9.3) and the median absolute neutrophil (ANC) nadir was 2.0 × 103/μl (range 0.4–7.2). Thrombocytopenia - 100.0 × 103/μl was observed in 15 patients; the median platelet nadir was 123.0 (range 30.0–245.0). All patients experienced a mild to moderate flu-like syndrome. In addition, one patient had a mild hemolytic-uremic syndrome which appeared related to gemcitabine therapy. Gemcitabine demonstrated marginal activity in this resistant neoplasm, without excessive toxicity. Further evaluation, including the use of more intense dosing and/or combination therapy, is warranted.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00873232
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  • 5
    Electronic Resource
    Electronic Resource
    Cardiovascular rhythm effects of gamma recombinant DNA interferon (1989)
    Springer
    Investigational new drugs 7 (1989), S. 275-280 
    Details
    ISSN: 1573-0646
    Keywords: gamma interferon ; cardiac rhythm disturbances
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Twenty patients receiving recombinant DNA gamma interferon were prospectively assessed for cardiac rhythm disturbances. All patients were evaluated with baseline electrocardiograms, pretreatment ambulatory monitoring and ejection fraction determination. Each patient was then monitored continuously during drug administration. Quantitative ventricular ectopy was not increased, nor were average heart rate, maximal heart rate, or quantitative supraventricular ectopy when comparing baseline to during therapy parameters. Complex cardiac ectopy and noteworthy cardiac events (NCE) were defined and identified in 2/20 (10%) patients pretreatment, and in 8/18 patients (44%) with normal baseline tracings during treatment (p = .02). This difference was not apparent when corrected for total days monitored pre and post treatment (p 〉 .2). These consisted predominantly of nonsustained short duration ventricular tachycardia (seven of eight patients). We conclude that life threatening cardiac events are uncommon with gamma interferon therapy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00170873
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  • 6
    Electronic Resource
    Electronic Resource
    A phase I clinical and pharmacokinetic study of the oral and the oral/ intravenous administration of menogaril (1993)
    Springer
    Investigational new drugs 11 (1993), S. 17-27 
    Details
    ISSN: 1573-0646
    Keywords: menogaril ; phase I ; pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Thirty-five patients with advanced refractory cancer were enrolled on this phase I study of menogaril administered orally every 4 weeks at dosages ranging from 85 mg/m2 to 625 mg/m2. An additional 12 patients received alternating oral and IV doses of menogaril (250 mg/m2 IV; 250–500 mg/m2 oral) with accompanying blood and urine sampling for pharmacokinetics analysis. Nausea and vomiting were the dose-limiting toxicities at the 625 mg/m2 dosage level; vomiting was inadequately relieved by prophylactic antiemetics at this dosage level. Other toxicities included sporadic leukopenia at all dosage levels; at dosages of 500 mg/m2 and 625 mg/m2, leukopenia 〈 3000/μl occurred in 7 of 24 patients. Anemia and thrombocytopenia were much less frequent toxicities. Among the patients receiving IV menogaril, peripheral vein phlebitis, leukopenia and anemia were the predominant toxicities. No antitumor responses were observed, yet one patient with nonsmall cell lung cancer experienced a 30% reduction in metastatic tumor nodules. For the patients receiving alternating oral and IV menogaril, comparative pharmacokinetic analyses were performed by HPLC. After oral administration, maximum plasma concentrations were achieved in an average of 6 hours; maximum plasma concentrations were less than one-quarter of those achieved after intravenous administration. The harmonic mean (±SD) terminal disposition half-life after oral dosing was 29.3 ±9.2 hours; mean systemic bioavailability was 33.6±10.5% after oral dosing. Forty-eight hours after an oral dose, mean cumulative urinary excretions of menogaril and the primary metabolite, N-demethylmenogaril, were 4.00±0.96% and 0.44±0.16%, respectively. Because of the poor tolerance of oral menogaril and minimal evidence of biological activity, this schedule of drug administration is not recommended for phase II evaluation. Based on this and other published studies of oral menogaril, frequent chronic low-intermediate dosages of the drug may be given orally with potentially better tolerance and antitumor activity.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00873906
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  • 7
    Electronic Resource
    Electronic Resource
    Phase II trial of trimetrexate in advanced esophageal cancer: A southwest oncology group study (1995)
    Springer
    Investigational new drugs 13 (1995), S. 363-365 
    Details
    ISSN: 1573-0646
    Keywords: phase II study ; trimetrexate ; advanced esophageal cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Trimetrexate (TMQ) is a synthetic folate antagonist that has demonstrated non-cross resistance with methotrexate in preclinical screens. A phase II trial was performed with TMQ given to patients with advanced squamous cell carcinoma of the esophagus. TMQ was administered as an i.v. bolus on a daily × 5 schedule, every 3 weeks; a starting dose of 12 mg/m2 was used for patients with no prior irradiation, and of 8 mg/m2 for patients with prior irradiation. Twenty-four patients were entered onto study, with 23 patients eligible, and a median of 2 courses of TMQ administered per patient. Twenty-three patients were evaluable for toxicity. Toxicities of SWOG grade ≥ 3 included granulocytopenia (9 patients), leukopenia (7 patients), thrombocytopenia (4 patients), anemia (3 patients), mucositis (3 patients), nausea and vomiting (2 patients), dermatitis (1 patient), diarrhea (1 patient), and fever (1 patient). Fifteen patients had some hematologic toxicity, and eleven patients had hematologic toxicity of grade ≥ 3. Two treatment related deaths occurred in association with myelosuppression. One patient achieved a complete response and one patient achieved a partial response, with response durations of 8.5 months and 6 months, respectively. The overall response rate was 8% [95% confidence interval of 1 to 28%], with a median survival for the 23 eligible patients of 5.1 months.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00873146
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  • 8
    Electronic Resource
    Electronic Resource
    Phase II trial of echinomycin in advanced colorectal cancer (1991)
    Springer
    Investigational new drugs 9 (1991), S. 113-114 
    Details
    ISSN: 1573-0646
    Keywords: phase II ; echinomycin ; colorectal ; cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00194561
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  • 9
    Electronic Resource
    Electronic Resource
    Working conference on biomodulator and chemotherapy combination therapies (1991)
    Springer
    Investigational new drugs 9 (1991), S. 209-214 
    Details
    ISSN: 1573-0646
    Keywords: biomodulator ; chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00175092
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  • 10
    Electronic Resource
    Electronic Resource
    Pharmacokinetic and phase I studies of brequinar (DUP 785; NSC 368390) in combination with cisplatin in patients with advanced malignancies (1998)
    Springer
    Investigational new drugs 16 (1998), S. 19-27 
    Details
    ISSN: 1573-0646
    Keywords: phase I ; brequinar ; DUP 785 ; cisplatin ; pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Brequinar (DUP 785; NSC 368390) is a quinoline carboxylic acid derivative that inhibits pyrimidine synthesis at the level of dihydro-orotate dehydrogenase and revealed synergy with cisplatin in preclinical models. In this study investigating the pharmacokinetic and toxicity of brequinar in combination with cisplatin, patients were initially treated with weekly brequinar, in combination with an every-three-week administration of cisplatin. Due to toxicity, the schedule was modified to a 28-day cycle with brequinar given on days 1, 8, 15, and cisplatin on day 1. A total of 24 patients (16 male, 8 female; median age 57; median performance status 1) received 69 courses of therapy. Six dose levels were explored, with cisplatin/ brequinar doses, respectively, of 50/500, 50/650, 50/860, 60/860, 75/650, and 75/860 mg/m2. The serum concentration versus time curves for brequinar were biphasic. A comparison of the pharmacokinetic results after the first and third doses of brequinar indicate that the presence of 50, 60, and 75 mg/m2cisplatin did not change the protein binding and the pharmacokinetics of brequinar in any of the three brequinar-dose groups. Total cisplatin plasma pharmacokinetic followed a triphasic-shape curve and unbound cisplatin decayed at a very rapid rate. Since pharmacokinetic parameters for total cisplatin in this study were similar to those reported in the literature, the presence of brequinar is unlikely to alter the pharmacokinetics of cisplatin. Main dose-limiting toxicities included myelosuppression (including neutropenia and thrombocytopenia) and mucositis. Cisplatin/brequinar doses of 50/500, 50/650, 50/860, 60/860, 75/650, and 75/860 mg/m2, were associated with dose limiting toxicity in 0/3, 1/3, 1/3, 1/3, 2/4, 2/5, and 4/6 patients, respectively. This study shows that co-administration of brequinar and cisplatin does not affect the pharmacokinetic properties of either drug and that the MTDs of cisplatin/brequinar combinations are 60/860 mg/m2 or 75/650 mg/m2. From this study, we conclude that full dose of 75 mg/m2 cisplatin (day 1) can be administered with 650 mg/m2 brequinar (days 1, 8 and 15) without significant modifications of individual drug pharmacokinetic parameters.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1016066529642
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