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   1 sion in rectal cancer patients enrolled in a phase I trial.                                          
     2 lind, placebo-controlled, within-dose cohort phase I trial.                                          
     3 carboplatin had acceptable tolerability in a phase I trial.                                          
     4  cell or adenocarcinoma were treated on this phase I trial.                                          
     5          Fifteen patients enrolled onto this phase I trial.                                          
     6       Eleven patients were entered onto this phase I trial.                                          
     7 s preclinical study, the authors performed a phase I trial.                                          
     8 by the minimal toxicity and survival in this phase I trial.                                          
     9 of a ligand fusion-protein, DAB389IL-2, in a phase I trial.                                          
    10  patients with sarcoma in a disease-specific phase I trial.                                          
    11 and normal CEA levels were eligible for this phase I trial.                                          
    12 e-escalation and single-stage expansion of a phase I trial.                                          
    13 enicity of RG7787 is now being assessed in a phase I trial.                                          
    14 bilization for three or more courses in this phase I trial.                                          
    15 n was well tolerated by CLL patients in this phase I trial.                                          
    16 termined by Monte Carlo simulation of 60,000 phase I trials.                                         
    17 tients was more frequent than predicted from phase I trials.                                         
    18  clinical trials but did not progress beyond phase I trials.                                         
    19 n the low likelihood of medical benefit from phase I trials.                                         
    20  should improve the safety and efficiency of phase I trials.                                         
    21 is and fatigue than was anticipated from the phase I trials.                                         
    22 ing such designs to guide dose escalation in phase I trials.                                         
    23 RT to better select appropriate patients for phase I trials.                                         
    24  feasibility of a novel two-stage design for phase I trials.                                         
    25 c indications, beginning with well-conducted phase I trials.                                         
    26  participation or of the research purpose of phase I trials.                                         
    27 -Hodgkin's lymphoma (NHL) in two concomitant phase I trials.                                         
    28 using a large patient database from multiple phase I trials.                                         
    29 es with survival, validating RECIST's use in phase I trials.                                         
    30 itors blocking this signaling cascade are in phase I trials.                                         
    31 al initiatives to assist communication about phase I trials.                                         
    32 selected cohort of 78 patients enrolled onto phase I trials.                                         
    33 tively in upcoming Children's Oncology Group phase I trials.                                         
    34 g steps is the initiation of first-in-human (phase I) trials.                                        
  
    36  Forty-nine children were enrolled onto this phase I trial (24 with acute nonlymphoblastic leukemia [
  
  
  
    40 er Therapeutics Evaluation Program-sponsored phase I trials activated between 2000 and 2010 was used.
    41 dren with cancer (n = 85) who were offered a phase I trial along with their parents and physicians.  
  
    43 sults of our pilot study do not suggest that phase I trials always cost payers more than standard tre
  
    45 ength of stay in the ICU was 3.7 days in the Phase I trial and a mean of 3 days in the Phase II trial
  
  
  
    49 nging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are d
    50 s about the emergence of multi-institutional phase I trials and about using the optimal biologic dose
    51 tanding of either provided information about phase I trials and alternatives to trial participation o
    52 ly ethical concerns regarding the conduct of phase I trials and had realistic expectations of the pot
    53 rent guidelines for the conduct of pediatric phase I trials and represents a consensus between Americ
  
  
    56 tastases might be appropriately entered into phase I trials, and we present our approach for their st
  
    58   This study was undertaken to determine how phase I trials are currently conducted and to provide a 
  
    60 atives to the standard design for conducting phase I trials are proposed with increasing frequency.  
    61 toxicity (DLT) help to assure that pediatric phase I trials are safely conducted and reliably identif
  
  
  
    65 py), with those choosing to participate in a phase I trial being more optimistic than those declining
    66 cted from 2,182 eligible patients treated in phase I trials between 2005 and 2007 in 14 European inst
    67 mic studies are frequently incorporated into phase I trials, but it is uncommon that they guide dose 
  
  
    70  efficacy of EGFR inhibitors, we performed a phase I trial combining dasatinib, an SFK and multikinas
    71 ltiply-relapsed B-cell NHL were treated in a phase I trial combining iodine-131 tositumomab (ranging 
    72 eriences with the interactive subject-choice phase I trial design and consent process, was conducted 
  
  
    75 f the traditional 3 + 3 patients per cohort, phase I trial design with a novel, rolling six design wa
    76  recombinant human endostatin (rh-Endo) in a phase I trial designed to assess safety, pharmacokinetic
    77  be used in combination with BCNU in another phase I trial designed to determine the maximal-tolerate
  
  
    80    Many parents of children participating in phase I trials do not understand the purpose of these tr
  
  
  
  
  
    86 Internet information and unproven therapies, phase I trial enrollment, and working as a multidiscipli
    87 likely to agree that alternate care plans to phase I trial entry had been explained (odds, 2.5; P = .
  
  
  
  
  
  
    94 e rate for one cycle of this therapy in this phase I trial for patients with leukemia was 18% (95% co
  
    96 ral solid tumor types, and the initiation of phase I trials for A2AR antagonists in oncology, this ap
    97 domains of diphtheria toxin, is presently in phase I trials for patients with resistant acute myeloid
  
    99 e clinical solution to challenges arising in phase I trials from the dose-dependent side effects of t
  
  
   102  Approximately 36% of patients enrolled onto phase I trials had mild renal dysfunction by FDA criteri
  
  
  
  
  
  
   109 data, coupled with the observations of a new phase I trial in human peripheral atherosclerosis, sugge
  
  
   112 een shown to possess antiviral activity in a phase I trial in patients chronically infected with geno
  
  
   115 growth factor, is currently the subject of a Phase I trial in patients with ischemic heart disease.  
   116 These preclinical studies were followed by a phase I trial in patients with neoplastic meningitis.   
  
  
   119 e antitumor immune responses, we conducted a phase I trial in patients with surgically resected adeno
  
   121 hicago who were eligible to participate in a phase I trial in which they underwent a three-step infor
  
   123 including Roneparstat, a modified heparin in phase I trials in myeloma patients, significantly inhibi
   124     Distinctive characteristics of pediatric phase I trials, in comparison to adult phase I trials, i
   125 atric phase I trials, in comparison to adult phase I trials, include the necessity for multiinstituti
  
  
  
  
   130  and in a patient with gastric cancer on the phase I trial led to this phase II study of flavopiridol
   131 ree end-of-life decisions: enrollment onto a phase I trial (n = 7), adoption of a do not resuscitate 
  
   133 odies and have permitted the initiation of a phase I trial of (211)At-labeled chimeric 81C6 administe
   134   The purpose of this study was to conduct a phase I trial of (90)Y-DOTATOC to determine the dose-tox
  
  
  
  
  
  
  
   142  vasculature of solid tumors, we performed a phase I trial of antibody J591, targeting the extracellu
  
  
  
  
  
  
  
  
   151 ive non-Hodgkin's lymphoma were treated on a phase I trial of dose escalation using the ProMACE-CytaB
   152 enrolled on a prospective single-institution phase I trial of dose-escalated hypofractionated RT with
  
  
  
  
   157  IL-2 regimen for testing this hypothesis, a phase I trial of IL-2 (Roche) was performed in children 
   158 he measured data in 10 of 14 patients in the phase I trial of intra-Ommaya radioimmunotherapy using (
   159 udy, we report the results of a first-in-man phase I trial of intranodal direct injection (IDI) of Ad
   160 r patients who failed chemotherapy entered a Phase I trial of intraperitoneal 177Lu-CC49 antibody.   
  
  
  
  
  
  
  
   168 reported up to 90% seroconversion rates in a phase I trial of live-attenuated dengue-virus vaccines i
  
  
  
  
  
  
  
  
  
  
  
  
   181 gator-initiated single-dose, dose-escalation phase I trial of RTX in chronic dialysis patients (PRA >
  
   183      The Children's Cancer Group conducted a phase I trial of temozolomide stratified by prior cranio
  
  
  
   187    We present the results of the first human phase I trial of the Ii-Key hybrid HER-2/neu peptide (AE
  
  
  
  
  
  
   194 es from breast cancer patients enrolled on a phase I trial of trastuzumab and IL-12, and found elevat
  
   196 in the first 5 participants enrolled in this phase I trial of virus-based gene transfer in this mitoc
  
   198 ta that have guided the design of subsequent phase I trials of ABT-888 in combination with DNA-damagi
   199 s peptide to NOD mice prevents diabetes, and phase I trials of an altered peptide ligand of B:9-23 ar
  
   201 ncer and Leukemia Group B conducted parallel phase I trials of cytarabine, daunorubicin, and etoposid
  
  
  
   205 reclinical glioma models, and have initiated phase I trials of these vaccines in patients with malign
   206 origin are used worldwide as xenografts, and phase I trials of viable pig pancreatic islets are curre
   207 y and alternative medicine (CAM) usage among phase I trial participants and to describe these patient
  
   209  communication and information sharing about phase I trial participation are often missing from inter
  
   211 erstanding of possible risks and benefits of phase I trial participation, through direct subject invo
   212 ts may provide useful supplementary data for phase I trials, particularly with regard to toxicity and
  
  
  
   216 and EMBASE, limiting studies to single-agent phase I trials recruiting adults and published after 200
   217 all molecule inhibitor MLN4924, currently in phase I trials, represents an unprecedented opportunity 
  
  
   220 s a good predictor of clinical response?; in phase I trials should effective biological dose, not max
  
  
  
   224 rties of imatinib were investigated during a phase I trial that included 64 adult patients with Phila
  
  
   227 d from 82 patients entered in four different phase I trials that were previously reported as separate
   228  studies demonstrated that in an HIV vaccine phase I trial, the DP6-001 trial, a polyvalent Env DNA p
  
  
  
  
   233  administered as primary cancer therapy in a phase I trial to determine (1) whether mixed chimerism c
  
  
  
   237 rexate (MTX) in lymphoblasts, we developed a phase I trial to determine the maximum-tolerated dose (M
  
  
  
   241  designed as a single-blind, escalating-dose phase I trial to evaluate the safety and immunogenicity 
  
   243 bjects were inoculated in an adaptive-design phase I trial to rapidly identify colonizing doses of NT
  
  
   246 d hypersensitivity reactions (HSRs), initial phase I trials used a 90-, 60-, 30-minute initial infusi
  
   248  Receiving cytotoxic chemotherapy as part of phase I trial was also associated with shorter median OS
  
  
   251 nd paclitaxel-resistant ovarian carcinoma, a phase I trial was conducted that combined increasing day
  
  
  
  
  
   257     This National Cancer Institute-sponsored phase I trial was designed to determine the feasibility 
  
  
  
  
  
  
  
  
  
   267 re observed in kidney cancer patients in the phase I trials, we performed a phase II trial of flavopi
  
   269 h the aim of improving patient selection for phase I trials, we previously performed a retrospective 
  
   271 eas 83% of UKCCSG respondents indicated that phase I trials were associated with ethical difficulties
  
  
  
   275      Advanced cancer patients enrolling onto phase I trials were surveyed regarding biologically base
   276 c, castration-resistant prostate cancer in a phase I trial where sequential cohorts were treated with
  
  
  
  
  
   282 ilot study the costs of care for patients on phase I trials with those incurred for standard treatmen
  
   284 ty-nine patient-subjects participated in the phase I trial, with 24 who agreed to and completed the s
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