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  • 1
    Keywords: SURVIVAL ; LUNG-CANCER ; DISEASE ; TRIAL ; MUTATIONS ; SQUAMOUS-CELL CARCINOMA ; HEAD ; pancreatic cancer ; NECK-CANCER ; GEMCITABINE ; clinical trial ; CLINICAL BENEFIT ; Advanced disease ; EGFR antibody ; H-R3 ; Nimotuzumab
    Abstract: Introduction Nimotuzumab is a humanized monoclonal antibody that binds to the EGFR. Based on phase I data, the recommended dose has been established at 200 mg weekly. This study was aimed at evaluating the safety and efficacy of nimotuzumab monotherapy in patients (pts) with locally advanced or metastatic pancreatic cancer. Methods Pts who failed first line standard chemotherapy for advanced disease and had at least one measurable lesion were eligible for the study. Nimotuzumab was given intravenously at 200 mg once weekly for 6 weeks (wks). Follow up by CT scan was performed after 8 weeks. Pts continued receiving treatment 3-weekly until disease progression or unacceptable toxicity occurred. Endpoints included tumor response (RECIST), progression-free survival (PFS), and safety. Results A total of 56 pts were enrolled for treatment (ECOG status of 1 [n=41] or 0 [n=15]), the majority (47 pts) had metastatic disease. Nearly half of the pts [n=26] received 〉= 2 regimens. Pts evaluable for response: n=36; CR: 0; PR: 0; SD: 6 pts. Median PFS for pts with SD was 19.2 weeks, for all pts 6.7 weeks (95% CI: 6.43-7.14 weeks). PFS after 1 year was 10.3% with a median overall survival of 18.1 weeks. Treatment-related adverse events were generally mild including rash grade 1 in 5 pts. After a single dose of 200 mg, the t(1/2) was calculated to 45 h. Conclusion These data confirm that nimotuzumab is safe and very well tolerated. To improve efficacy, a randomized, placebo-controlled trial with Gem has been initiated
    Type of Publication: Journal article published
    PubMed ID: 21170759
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  • 2
    Keywords: SPECTRA ; tumor ; human ; IN-VIVO ; IMAGES ; SYSTEM ; SYSTEMS ; VOLUME ; SITE ; DRUG ; TISSUE ; TUMORS ; TIME ; animals ; CONTRAST AGENT ; MR ; MRI ; treatment ; F-19 NMR ; INVIVO ; MAGNETIC-RESONANCE ; RESONANCE SPECTROSCOPY ; SPECTROSCOPY ; magnetic resonance imaging ; TARGET ; IDENTIFICATION ; PRODUCT ; positron emission tomography ; POSITRON-EMISSION-TOMOGRAPHY ; PET ; FLUOROURACIL ; KINETICS ; PHARMACOKINETICS ; GD-DTPA ; MRS ; nuclear magnetic resonance spectroscopy ; 5- FLUOROURACIL ; dynamic magnetic resonance imaging
    Abstract: Positron emission tomography (PET) and nuclear magnetic resonance spectroscopy (MRS) are two techniques that allow the noninvasive monitoring of drug distribution in living systems (humans, animals), and dynamic contrast-enhanced magnetic resonance imaging (dMRI) provides noninvasive physiological information relevant for drug distribution. PET yields series of cross-sectional images that can be used to monitor the absolute radioactivity concentrations in tissues pixel-by- pixel, but does not allow direct identification of each of the products present. MRS produces spectra showing changes in the concentration of both the parent drug and of the metabolites separately for a sensitive volume, but does not provide a simple means for measuring absolute concentrations. dMRI, which measures the changes in the rates of relaxation of water, proportional to the concentrations of the contrast agent (usually Gd-DTPA), readily allows the determination of functional changes in cross-sectional images down to a pixel- by-pixel level. All of these methods are of special interest to evaluate the amounts of drug that can reach the target tissue, penetrate it, remain present at such targets for a sufficient length of time, and how they are metabolized at the target site. Such information may be of particular interest in the study of solid malignant tumors and may become very relevant for determining better treatment strategies. This article presents examples of successful studies of tissue pharmacokinetics with MRS and dMRI. The following article is devoted to PET
    Type of Publication: Journal article published
    PubMed ID: 12889737
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  • 3
    ISSN: 1573-0646
    Keywords: LY 186641 ; diarylsulfonylurea ; renal cell cancer ; phase II
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary LY 186641 is a diarylsulfonylurea with a broad spectrum antitumor activity against both murine and human solid tumors. We report here the results of a phase II trial of LY 186641 in advanced renal cell adenocarcinoma. The drug was administered orally, once daily for 2 weeks, every 21 days at a 700 mg/m2/d dose. Sixteen patients were enrolled in this phase II trial; 12 males, 4 females, with a median age of 58 years. All patients had progressive measurable metastatic disease. The primary tumor was surgically removed in all but one patient. Three patients were previously treated by biologic response modifiers (BRMs). A total of 72 courses were administered. The most common side effects were methemoglobulinemia (MetHgb) and anemia which occurred in 13 and 10 patients respectively. The MetHgb did not exceed 15%, and only 3 patients required blood transfusion for grade 3 (2 patients) and grade 4 (1 patient) anemia. Reversible hepatotoxicity was observed in 3 patients. There were one pathological complete response, seven stable disease and 8 progressive disease.
    Type of Medium: Electronic Resource
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  • 4
    Electronic Resource
    Electronic Resource
    Springer
    Investigational new drugs 1 (1983), S. 189-189 
    ISSN: 1573-0646
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
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  • 5
    Electronic Resource
    Electronic Resource
    Springer
    Investigational new drugs 1 (1983), S. 195-195 
    ISSN: 1573-0646
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Type of Medium: Electronic Resource
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  • 6
    ISSN: 1573-0646
    Keywords: teniposide ; gastric cancer
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The Southwest Oncology Group conducted a trial of VM-26 (teniposide) in patients with advanced gastric cancer. VM-26 60 mg/m2 IV infusion over 30–45 minutes was given daily for 5 days every 21 days. Twentyone eligible patients with measurable disease and a SWOG performance status of 0–2 were analyzed for response and toxicity. Partial responses were seen in 2 of the 21 eligible patients (9.5%). Median survival was 3.8 months. Severe or life-threatening toxicity was observed in 13/21 (62%) patients. This included two drug related deaths related to neutropenic sepsis and seven other patients with grade 4 granulocytopenia (〈 500/mm3). Liver dysfunction and hypotension were seen less often and were not dose limiting. Although the modest activity seen was comparable to that of VP-16 (etoposide) as a single agent, the hematologic toxicity observed in this trial would likely preclude further trials of VM-26 (teniposide) in advanced gastric cancer.
    Type of Medium: Electronic Resource
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  • 7
    Electronic Resource
    Electronic Resource
    Springer
    Investigational new drugs 12 (1994), S. 1-13 
    ISSN: 1573-0646
    Keywords: multidrug resistance ; p-glycoprotein ; chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Resistance to chemotherapy is the single most important reason for treatment failure in cancer patients. Over the past 15 years, we have gained significant insight into one of the mechanisms responsible for this process: multidrug resistance (MDR). Far from being a phenomenon limited to the laboratory, multidrug resistance has been identified in a wide variety of newly diagnosed and recurrent human tumors. A number of compounds can block p-glycoprotein and overcome MDRin vitro andin vivo. Current strategies to block MDR are discussed in this review. Future research in this area will focus on the identification of more selective and potent MDR reversing agents and the development of entirely new approaches to overcoming multidrug resistance such as monoclonal antibodies, immunotoxins, and gene therapy.
    Type of Medium: Electronic Resource
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  • 8
    ISSN: 1573-0646
    Keywords: piroxantrone ; soft tissue sarcoma
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Piroxantrone is an anthrapyrazole compound undergoing phase II testing in a variety of diseases. The anthrapyrazoles are a series of compounds synthesized with the intent of maintaining the broad antitumor activity of anthracyclines, but with lessened cardiac toxicity. The Southwest Oncology Group (SWOG) conducted a phase II trial of piroxantrone in advanced soft tissue sarcoma. Treatment consisted of piroxantrone 150 mg/M2 administered intravenously over 1 hour every 21 days. Twenty-five eligible patients were registered to the trial. Twenty-three patients received treatment and are fully evaluable for response and toxicity. Two partial responses were seen for an overall response rate of 9% (95% confidence limit 1%–28%). Abnormal cardiac ejection fraction occurred in five patients, and fatal congestive heart failure developed in one patient on study. Toxicities other than cardiac were tolerable. Based on the observed response rate and cardiac toxicity, further trials of piroxantrone in the treatment of soft tissue sarcoma do not appear warranted.
    Type of Medium: Electronic Resource
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  • 9
    ISSN: 1573-0646
    Keywords: bryostatin-1 ; phorbol ester ; protein kinase C ; carcinoma cell lines ; proliferation ; c-myc oncogene
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Bryostatin 1 (Bryo) is a naturally occurring macrocyclic lactone with antineoplastic activity. Like the phorbol ester 12-O-tetradecanoyl-phorbol 13-acetate (TPA) it directly activates the calcium- and phospholipid-dependent protein kinase C (PKC), thus generating a number of different cellular responses. We investigated the effects of Bryo and TPA on DNA synthesis, proliferation, viability and c-myc protooncogene expression of the human carcinoma cell lines COLO-320, MEL-HO, and KB-3-1. TPA inhibited [3H]-thymidine incorporation in all three cell lines in a dose-dependent manner, whereas Bryo only inhibited the DNA synthesis in MEL-HO, but not in KB-3-1 and COLO-320 cells. Within the concentration ranges used, TPA and Bryo were found to have a low toxicity. Counting of the cells confirmed the observed inhibition of cell proliferation. However, the enzymatic conversion of MTT, applied as a colorimetric proliferation assay, was not significantly affected by both biomodulators. Time-course experiments revealed a rapid onset of the inhibitory effect on DNA synthesis. Bryo was further able to antagonize the TPA-mediated effects on proliferation suggesting an (at least partially) different mode of action of these PKC activators. Incubation of MEL-HO and COLO-320 cells with either of the two biomodulators resulted in a rapid and strong increase of c-myc mRNA. The present study emphasizes Bryo as an interesting, natural substance for the study of PKC-mediated biological effects.
    Type of Medium: Electronic Resource
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  • 10
    ISSN: 1573-0646
    Keywords: Interferon alpha ; difluoromethylornithine ; doxorubicin ; polyamine metabolism ; advanced malignancies
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Interferon (IFN) and conventional cytotoxic chemotherapeutic agents have been successfully combined in various studies. Alpha difluoromethylornithine (DFMO) is a novel antitumor agent which is an inhibitor of polyamine metabolism. A phase I study of IFN 24 × 106 U/m2/day IM (days 3–7), DFMO 9 gm/m2 p.o. daily (days 1–7), and a variable dose of doxorubicin starting at 20 mg/m2 (day 6), of each 28 day cycle was performed. The aim of the study was to determine the maximally tolerable dose of doxorubicin in this combination. Three patients were treated with doxorubicin at 20 mg/m2 and six patients at 40 mg/m2. The dose limiting toxicities were neutropenia, fatigue and fever. All other toxicities were mild and there was no grade IV toxicity. A doxorubicin dose of 40 mg/m2 produced tolerable toxicity and is recommended for phase II studies. No major antitumor effects were seen.
    Type of Medium: Electronic Resource
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