Search results for "PHASE"
showing 10 items of 6344 documents
A phase I dose-escalation study of the immunocytokine EMD 521873 (Selectikine) in patients with advanced solid tumours.
2012
Abstract Background EMD 521873 (Selectikine), an immunocytokine comprising a DNA-targeting antibody, aimed at tumour necrosis, fused with a genetically modified interleukin-2 (IL-2) moiety, was investigated in this first-in-human phase I study. Methods Patients had metastatic or locally advanced solid tumours failing previous standard therapy. Selectikine was administered as a 1-hour intravenous infusion on 3 consecutive days, every 3weeks. A subgroup of patients also received 300mg/m 2 cyclophosphamide on day 1 of each cycle. Escalating doses of Selectikine were investigated with the primary objective of determining the maximum tolerated dose (MTD). Results Thirty-nine patients were treate…
Cisplatin and gemcitabine with either vinorelbine or paclitaxel in the treatment of carcinomas of unknown primary site : results of an Italian multic…
2006
BACKGROUND. To date, the standard treatment for patients who have carcinoma of unknown primary site has not been established. METHODS. In this randomized Phase II study, 66 previously untreated patients (33 patients per arm) with carcinomas of unknown primary site received cisplatin (35 mg/m2) and gemcitabine (1000 mg/m2) with either paclitaxel (70 mg/m2) or vinorelbine (25 mg/m2), and all drugs were administered intravenously on Days 1 and 8 of a 21-day cycle. Twenty-nine patients (44%) presented with ≥2 involved sites. The pathologic diagnosis was mainly adenocarcinoma (48 patients; 72.7%) and squamous carcinoma (7 patients; 10.6%). RESULTS. In the first arm, 16 patients (48.5%) experienc…
Phase I/II study of pixantrone in combination with cyclophosphamide, vincristine, and prednisone in patients with relapsed aggressive non-Hodgkin lym…
2011
Pixantrone is a potentially more effective, less cardiotoxic alternative to doxorubicin for patients with aggressive non-Hodgkin lymphoma (aNHL). This phase I/II non-comparative study evaluated pixantrone in place of doxorubicin in the standard CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone), i.e. CPOP (cyclophosphamide, pixantrone, vincristine, and prednisone), in patients with relapsed aNHL who had previously received CHOP ± rituximab. Patients were administered pixantrone on day 1 of each 21-day cycle. Phase I (n = 35) dose escalation from 80 mg/m(2) to 180 mg/m(2) established the phase II (n = 30) dose as 150 mg/m(2). In phase II, 20 patients (67%) received all…
Randomised phase II evaluation of irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) vs 5-fluorouracil, leucovorin, and etoposide (ELF) in…
2005
An open-label randomised comparison of efficacy and tolerability of irinotecan plus high-dose 5-fluorouracil (5-FU) and leucovorin (LV) (ILF) with etoposide plus 5-FU/LV (ELF) in patients with untreated metastatic or locally advanced gastric cancer. One cycle of ILF comprised six once-weekly infusions of irinotecan 80 mg m(-2), LV 500 mg m(-2), 24-h 5-FU 2000 mg m(-2), and ELF comprised three once-daily doses of etoposide 120 mg m(-2), LV 300 mg m(-2), 5-FU 500 mg m(-2). In all, 56 patients received ILF and 58 ELF. Median age was 62 years, Karnofsky performance 90%, and disease status was comparable for both arms. The objective clinical response rates after 14 weeks treatment (primary end p…
Lack of efficacy of recombinant human interleukin-6 in patients with advanced renal cell cancer: results of a phase II study.
1998
The present phase II study was undertaken to assess antitumoral activity, safety and tolerability of recombinant human interleukin-6 (rh IL-6) in patients with advanced renal cell cancer. Rh IL-6 was administered as a daily subcutaneous injection at a fixed dose of 150 micrograms/day for a maximum of 42 consecutive days. 12 patients with metastatic renal cell cancer without previous immunotherapy were enrolled and were evaluated for response. No objective clinical responses were observed in the trial. Toxicity was moderate and reversible and mainly comprised fever, influenza-like symptoms, fatigue and moderate hepatotoxicity. Anaemia, leucocytosis, thrombocytosis and induction of an acute p…
A phase II trial of chimeric monoclonal antibody G250 for advanced renal cell carcinoma patients.
2004
Contains fulltext : 57114.pdf (Publisher’s version ) (Closed access) Chimeric monoclonal antibody G250 (WX-G250) binds to a cell surface antigen found on >90% of renal cell carcinoma (RCC). A multicentre phase II study was performed to evaluate the safety and efficacy of WX-G250 in metastatic RCC (mRCC) patients. In all, 36 patients with mRCC were included. WX-G250 was given weekly by intravenous infusion for 12 weeks. Patients with stable disease (SD) or response were eligible to receive additional treatment for 8 weeks. None of the 36 enrolled patients experienced any drug-related grade III or IV toxicity. Only three patients had grade II toxicity possibly related to the study medication.…
Negative emotional state modulates visual working memory in the late consolidation phase
2020
Although a considerable literature has grown up around the interactions between emotional state and visual working memory (VWM) performance, the mechanism underlying the impact of the negative emotional state on VWM remains unclear. The present study aimed to test whether the influence of emotional state is related to the early phase or late phase of VWM consolidation process. Across three experiments, we found that the negative emotional state did not affect VWM performance when the presentation time of stimuli was short. However, when the presentation time was long, the negative emotional state increased the VWM precision and reduced the VWM number. According to the two-phase model propos…
Malondialdehyde in early phase of acute pancreatitis
2011
Aims: to assess oxidative stress in acute pancreatitis, its evolution over time and its relationship with the severity of the disease. Methods: during a two-year period, patients with acute pancreatitis with less than 24 hours of pain were evaluated. Serum was obtained the first, second and fourth day from admittance, if complications were detected, and after recovery. Malondialdehyde was determined by high performance liquid chromatography. Twenty healthy volunteers constituted the control group. Malondialdehyde between groups was compared with Mann-Whitney and Kruskal-Wallis tests; malondialdehyde evolution was studied with Wilcoxon test. Results: one hundred and sixty-nine patients were …
Reproducibility of multiphase pseudo-continuous arterial spin labeling and the effect of post-processing analysis methods
2015
Arterial spin labeling (ASL) is an emerging MRI technique for non-invasive measurement of cerebral blood flow (CBF). Compared to invasive perfusion imaging modalities, ASL suffers from low sensitivity due to poor signal-to-noise ratio (SNR), susceptibility to motion artifacts and low spatial resolution, all of which limit its reliability. In this work, the effects of various state of the art image processing techniques for addressing these ASL limitations are investigated. A processing pipeline consisting of motion correction, ASL motion correction imprecision removal, temporal and spatial filtering, partial volume effect correction, and CBF quantification was developed and assessed. To fur…
Nonlinear analysis of continuous ECG during sleep I. Reconstruction.
2000
In recent years evidence has accumulated that ECG signals are of a nonlinear nature. It has been recognized that strictly periodic cardiac rhythms are not accompanied by healthy conditions but, on the contrary, by pathological states. Therefore, the application of methods from nonlinear system theory for the analysis of ECG signals has gained increasing interest. Crucial for the application of nonlinear methods is the reconstruction (embedding) of the time series in a phase space with appropriate dimension. In this study continuous ECG signals of 12 healthy subjects recorded during different sleep stages were analysed. Proper embedding dimension was determined by application of two techniqu…