Isotype matched anti bodies were used as controls. For analysis of antigen specific T cell responses 5 105 PBMC were plated in 96 well plates and 1 uM peptide was selleck chem Temsirolimus added. IFN was mea sured in supernatants after 24 hours by ELISA and prolif eration was measured by H 3 thymidine Inhibitors,Modulators,Libraries incorporation after 72 hours. Antigen specific T cell responses were analyzed before treatment and 3, 6 and 12 weeks after first peptide vaccination. Statistical analysis The primary endpoint of this study was response rate according to RECIST after 6 months. All eligible patients who began treatment were considered assessable for the primary end point. The primary efficacy endpoint, the response rate according to modified RECIST, was based on the Best Overall Response and was to be presented using frequency count and percentage.

The number of patients in the considered analysis popu lation was used as denominator for calculation of the rate. The 95% confidence interval around the response rate was also to be presented. The analysis of the Inhibitors,Modulators,Libraries primary end point was to be presented for the Intent to Treat population. Secondary end points included TTP, time to symptomatic progression, PFS, toxicity profile and immune responses. TTSP was defined as the time from the date of the first administration of GV1001 to the date of symptomatic Inhibitors,Modulators,Libraries progression or death. The change in perfor mance status was confirmed after 2 weeks. Subjects who had no documented symptomatic progression at the end of the study or who were lost to follow up prior to having symptomatic progression were censored at the date of their last visit or contact.

OS was not a pre defined End point. Kaplan Meier methodology was used Inhibitors,Modulators,Libraries to describe the distribution of TTP, PFS, TTSP and survival. All anal yses were performed using SAS version 8. 1 or later. Results Characteristics of patients 40 patients with advanced HCC were enrolled between November 2006 and April 2008 at three differ ent European centers. 14 patients were enrolled in Spain, 12 patients in Germany and 14 patients in France. Alco holic liver cirrhosis was the predominant cause of liver disease and 95% of the patients had a Child Pugh A liver cirrhosis. 26 patients had a BCLC tumor stage of C. A summary of the baseline characteristics of all patients is presented in Table 1.

All patients were eligible Inhibitors,Modulators,Libraries for safety and efficacy analysis, with the exception of three patients, which were not assessable http://www.selleckchem.com/products/ganetespib-sta-9090.html due to clinical progression or death before the treatment was initiated. Clinical trial conduct According to the protocol, the recruitment of patients was stopped after the first interim analysis once 40 patients had been enrolled in this trial. At this time point treatment was stopped in 8 patients prior to three months of treatment, in 16 patients between months 3 and 6, in 7 patients between months 6 and 9 and in 7 patients between months 9 and 12. Two patients received treatment for more than 12 months.