Patients with inoperable pancreatic cancer have a dismal prognosis with a mean life expectancy of 3 -6 months. New treatment modalities are thus urgently needed. Telomerase is expressed in 85 -90% of pancreas cancer, and immunogenic telomerase peptides have been characterised. A phase I/II study was conducted to investigate the safety, tolerability, and immunogenecity of telomerase peptide vaccination. Survival of the patients was also recorded. Forty-eight patients with non-resectable pancreatic cancer received intradermal injections of the telomerase peptide GV1001 at three dose levels, in combination with granulocyte -macrophage colonystimulating factor. The treatment period was 10 weeks. Monthly booster vaccinations were offered as follow-up treatment. Immune responses were measured as delayed-type hypersensitivity skin reaction and in vitro T-cell proliferation. GV1001 was well tolerated. Immune responses were observed in 24 of 38 evaluable patients, with the highest ratio (75%) in the intermediate dose group. Twenty-seven evaluable patients completed the study. Median survival for the intermediate dose-group was 8.6 months, significantly longer for the low-(P ¼ 0.006) and high-dose groups (P ¼ 0.05). One-year survival for the evaluable patients in the intermediate dose group was 25%. The results demonstrate that GV1001 is immunogenic and safe to use. The survival data indicate that induction of an immune response is correlated with prolonged survival, and the vaccine may offer a new treatment option for pancreatic cancer patients, encouraging further clinical studies.
Acute ischemic stroke is the leading cause of death and causing permanent disability in adults worldwide. In acute ischemic stroke, IL-6 levels positively correlated to more severe neurological deficits, more extensive brain damage and worse prognoses. The use of statin was associated with milder initial stroke severity, better functional outcome and lower mortality. This clinically randomized controlled trial study was aimed to analyze the serum levels of IL 6 in acute ischemic stroke patients who treated with Simvastatin 20 mg compare to placebo. Samples were taken using consecutive sampling method from hospitalized acute ischemic stroke patients in Neurology Department of Dr. Soetomo Teaching Hospital Surabaya and Airlangga University Hospital Surabayafrom August to November 2017. Total of 44 patients met the inclusion criteria, consisting of 22 patients in treatment group and 22 patients in control group.There were no significant difference in the characteristic of the patients in both groups (p>0.05). Averages of serum IL-6 in the control and the treatment group are 38.594±74.313 and 17.760±25.253(p=0,438) while averages of serum IL-6 post in the control group and the treatment are 46.586±103.484 and 15.275±17.183 (p=0,589). There were no significant level escalation in pre and post of control group (p = 0.205) and also no significant level reduction in pre and post of treatment group (p = 0.411), while the average difference in the control group (-7.992 + 78.912 pg/ml) and in the treatment group (2.485 + 23.738 pg/ml).
Acute ischemic stroke is the leading cause of death and causing permanent disability in adults worldwide. In acute ischemic stroke, IL-6 levels positively correlated to more severe neurological deficits, more extensive brain damage and worse prognoses. The use of statin was associated with milder initial stroke severity, better functional outcome and lower mortality. This clinically randomized controlled trial study was aimed to analyze the serum levels of IL 6 in acute ischemic stroke patients who treated with Simvastatin 20 mg compare to placebo. Samples were taken using consecutive sampling method from hospitalized acute ischemic stroke patients in Neurology Department of Dr. Soetomo Teaching Hospital Surabaya and Airlangga University Hospital Surabaya from August to November 2017. Total of 44 patients met the inclusion criteria, consisting of 22 patients in treatment group and 22 patients in control group. There were no significant difference in the characteristic of the patients in both groups (p>0.05). Averages of serum IL-6 in the control and the treatment group are 38.594±74.313 and 17.760±25.253 (p=0,438) while averages of serum IL-6 post in the control group and the treatment are 46.586±103.484 and 15.275±17.183 (p=0,589). There were no significant level escalation in pre and post of control group (p=0.205) and also no significant level reduction in pre and post of treatment group (p=0.411), while the average difference in the control group (-7.992 ± 78.912 pg/ml) and in the treatment group (2.485 ± 23.738 pg/ml).
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