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IntroductionHypothalamic-pituitary-adrenal (HPA) deregulation is commonly observed in cancer patients, but its clinical significance is not well understood. We prospectively examined the association between HPA activity, tumor-associated inflammation, and survival in ovarian cancer patients prior to treatment.Materials and methodsParticipants were 113 women with ovarian cancer who provided salivary cortisol for three days prior to treatment for calculation of cortisol slope, variability, and night cortisol. Cox proportional hazard regression analyses were used to examine associations between cortisol and survival in models adjusting for disease stage, tumor grade, cytoreduction and age. On a subsample of 41 patients with advanced disease ascites fluid was assayed for levels of interleukin-6 (IL-6) and correlated with cortisol variables.ResultsEach cortisol measure was associated with decreased survival time, adjusting for covariates (all p<.041). A one standard deviation increase in night cortisol was associated with a 46% greater likelihood of death. Patients in the high night cortisol group survived an estimated average of 3.3 years compared to 7.3 years for those in the low night cortisol group. Elevated ascites IL-6 was associated with each cortisol measure (all r>36, all p<.017).DiscussionAbnormal cortisol rhythms assessed prior to treatment are associated with decreased survival in ovarian cancer and increased inflammation in the vicinity of the tumor. HPA abnormalities may reflect poor endogenous control of inflammation, dysregulation caused by tumor-associated inflammation, broad circadian disruption, or some combination of these factors. Nocturnal cortisol may have utility as a non-invasive measure of HPA function and/or disease severity.

IntroductionHypothalamic-pituitary-adrenal (HPA) deregulation is commonly observed in cancer patients, but its clinical significance is not well understood. We prospectively examined the association between HPA activity, tumor-associated inflammation, and survival in ovarian cancer patients prior to treatment.Materials and methodsParticipants were 113 women with ovarian cancer who provided salivary cortisol for three days prior to treatment for calculation of cortisol slope, variability, and night cortisol. Cox proportional hazard regression analyses were used to examine associations between cortisol and survival in models adjusting for disease stage, tumor grade, cytoreduction and age. On a subsample of 41 patients with advanced disease ascites fluid was assayed for levels of interleukin-6 (IL-6) and correlated with cortisol variables.ResultsEach cortisol measure was associated with decreased survival time, adjusting for covariates (all p<.041). A one standard deviation increase in night cortisol was associated with a 46% greater likelihood of death. Patients in the high night cortisol group survived an estimated average of 3.3 years compared to 7.3 years for those in the low night cortisol group. Elevated ascites IL-6 was associated with each cortisol measure (all r>36, all p<.017).DiscussionAbnormal cortisol rhythms assessed prior to treatment are associated with decreased survival in ovarian cancer and increased inflammation in the vicinity of the tumor. HPA abnormalities may reflect poor endogenous control of inflammation, dysregulation caused by tumor-associated inflammation, broad circadian disruption, or some combination of these factors. Nocturnal cortisol may have utility as a non-invasive measure of HPA function and/or disease severity.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight week session during the summer of 2013. Students were supported by this grant and by grants awarded in 2012 and 2013. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor s laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. One of the students graduated and has been accepted into the Interdisciplinary Graduate Program in Immunology at the University of Iowa. All of the remaining students are continuing their undergraduate education at Lincoln University., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight week session during the summer of 2013. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. Of the students that have graduated from Lincoln, approximately two thirds are attending postgraduate programs., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for each of the eight week sessions during the summers of 2013 and 2014. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students work diligently on their research project, participate in meetings of the mentor s laboratory, attend workshops and seminars associated with our and other summer programs, and attend a special course in prostate cancer. We integrate the Lincoln students into social programs held throughout the campus for summer interns. At the end of the summer sessions the students present a poster of the research results from the summer experience. They also present the results of their research in the fall at Lincoln University. Of the students that have graduated from Lincoln, approximately two thirds are attending postgraduate programs., The original document contains color images. Supported in part by W81XWH-07-1-0241, W81XWH-09-1-0270, W81XWH-10-1-0459, W81XWH-12-1-0117.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight week session during the summer of 2013. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor's laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. Of the students that have graduated from Lincoln, approximately two thirds are attending postgraduate programs., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 25 students from Lincoln University for the eight week session during the summers of 2010, 2011, 2012, and 2013. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor s laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conferences. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. Of the students that have graduated from Lincoln, 63.6% are attending or have attended postgraduate programs, but when combined with students who are working in science the percentage rises to 78.8%. Others are working and applying to either medical school or graduate school and when those are combined with the previous two categories the percentage becomes 90.9%., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight week session during the summer of 2012. Four of the students were supported by this grant and four of the students were supported by the second grant awarded in 2010. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor s laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. One of the students graduated and has been accepted into the Interdisciplinary Graduate Program in Immunology at the University of Iowa. All of the remaining students are continuing their undergraduate education at Lincoln University., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 17 students from Lincoln University for the eight week session during the summers of 2010, 2011, and 2012. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor s laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conferences. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. Of the students that have graduated from Lincoln, approximately 72.4% are attending postgraduate programs., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight week session during the summer of 2011. One student canceled at the last moment for personal reasons. Four of the students were supported by this grant and three of the students were supported by the second grant awarded in 2011. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor s laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. All of the students are continuing their undergraduate education at Lincoln University., The original document contains color images.

The purpose of the research supported by this award is to conduct a Phase II clinical trial (study) of an adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols have been used in the trial: #1 - Phase II study of Adenovirus/PSA vaccine in men with recurrent prostate cancer after local therapy; and #2 - Phase II study of Adenovirus/PSA vaccine in men with hormone refractory prostate cancer. In the first protocol men with newly recurrent prostate cancer were randomized to one of two arms of the study. Patients in Arm A received the Ad/PSA vaccine only; three injections spaced 30 days apart. Patients in Arm B received androgen deprivation therapy (ADT) followed at day 14 by the Ad/PSA vaccine, again with three injections. In the second protocol men with hormone refractory prostate cancer were injected with the vaccine only, three injections 30 days apart. The patients were followed for toxicity, the development of anti-PSA immune responses, and evidence of a clinical effect of the vaccination. The latter includes changes in serum PSA and prostatic acid phosphatase (PAP) levels and in the PSA doubling times (PSADT). Patients in protocol #2 also have CT and bone scans to monitor., The original document contains color images.

The purpose of the research supported by this award is to conduct a Phase II clinical trial (study) of an adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols have been used in the trial: #1 - Phase II study of Adenovirus/PSA vaccine in men with recurrent prostate cancer after local therapy; and #2 - Phase II study of Adenovirus/PSA vaccine in men with hormone refractory prostate cancer. In the first protocol men with newly recurrent prostate cancer were randomized to one of two arms of the study. Patients in Arm A received the Ad/PSA vaccine only; three injections spaced 30 days apart. Patients in Arm B received androgen deprivation therapy (ADT) followed at day 14 by the Ad/PSA vaccine, again with three injections. In the second protocol men with hormone refractory prostate cancer were injected with the vaccine only, three injections 30 days apart. The patients were followed for toxicity, the development of anti-PSA immune responses, and evidence of a clinical effect of the vaccination. The latter includes changes in serum PSA and prostatic acid phosphatase (PAP) levels and in the PSA doubling times (PSADT). Patients in protocol #2 also have CT and bone scans to monitor their prostate cancer., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 10 students from Lincoln University for the eight week session during the summer of 2010. Three of the students were supported by this grant, five of the students were supported by the second grant awarded in 2007, and 2 were supported by a no-cost extension of a previous grant award.. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor's laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conference at Ohio State University. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. All of the students are continuing their undergraduate education at Lincoln University.

The HBCU Summer Research Training program accepted a total of 17 students from Lincoln University for the eight week session during the summers of 2010 and 2011. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor's laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 28 students from Lincoln University for the eight week session during the summers of 2007 through 2010. Fourteen of the students were supported by this grant and fourteen of the students were supported by other grants awarded in 2006 and 2009. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor s laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conferences at Purdue University, Michigan State University, University of Michigan, and Ohio State University. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented their results of their research in the fall at Lincoln University and at the 2007 and 2011 IMPaCT conferences. Sixty eight percent of the students that graduated from Lincoln have participated in postgraduate programs., The original document contains color images.

The Historically Black Colleges and Universities (HBCU) Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight-week session during the summer of 2009. One student canceled at the last minute, leaving 7 students in the program. Three of the students were supported by the original grant, awarded in 2006, and four of the students were supported by the second grant, which was awarded in 2007. Each student was assigned to the laboratory of a participating mentor and also was paired with a member of the mentor's laboratory. This laboratory member assisted with the day-to-day aspects of the research project. During the summer the students worked diligently on their research projects, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns, and they attended and participated in the CIC Conference at the University of Michigan. At the end of the summer session, the students presented a poster of the research results from their summer experience. They also presented the results of their research at Lincoln University in the fall., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight week session during the summer of 2009. Three of the students were supported by this grant and five of the students were supported by the second grant awarded in 2007. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor's laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conference at the University of Michigan. At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University. All of the students are continuing their undergraduate education at Lincoln University., The original document contains color images.

The purpose of the research supported by this award is to conduct a Phase II clinical trial (Study) of an adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols are being used in the trial: #1 - Phase II study of adenovirus/PSA vaccine in men with recurrent prostate cancer after local therapy, and #2 - Phase II study of adenovirus/PSA vaccine in men with hormone refractory prostate cancer. In the first protocol men with recent documentation of recurrent prostate cancer are randomized to one of two arms of the study. Patients in Arm A receive the Ad/PSA vaccine only; three injections spaced 30 days apart. Patients in Arm B will receive androgen deprivation therapy (ADT) followed at day 14 by the first of three Ad/PSA injections. In the second protocol men with hormone refractory prostate cancer are injected with the vaccine only, three injections 30 days apart. The patients are followed for toxicity, the development of anti-PSA immune responses, and evidence of a clinical effect of the vaccination. The latter includes changes in serum PSA and prostatic acid phosphatase (PAP), and the PSA doubling times (PSADT). Patients in protocol #2 also have CT and bone scans to monitor their prostate cancer.

The HBCU Summer Research Training Program accepted a total of 8 students from Lincoln University for the eight week session during the summer of 2008. Three of the students were supported by this grant and five of the students were supported by the second grant awarded in 2007. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor's laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conferences at the University of Illinois (2006), Purdue University (2007), and Michigan State University (2008). At the end of the summer sessions the students presented a poster of the researchresults from the summer experience. They also presented the results of their research in the fall at Lincoln University and some presented at the DOD's IMPaCT meeting in the Fall of 2007. Of the 14 total students, ten have graduated and the remainder are continuing their undergraduate education at Lincoln University. Of the ten graduates, two are in medical school, eight are in graduate school, and one currently working and applying to graduate schools., The original document contains color images.

The HBCU Summer Research Training Program accepted a total of 21 students from Lincoln University for the eight week session during the summers of 2006-2008. Fifteen of the students were supported by this grant and six of the students were supported by the second grant awarded in 2007. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor?s laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conferences at the University of Illinois (2006), Purdue University (2007), and Michigan State University (2008). At the end of the summer sessions the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University and some presented at the DOD?s IMPaCT meeting in the Fall of 2007. Of the 21 students, nine have graduated and the remainder are continuing their undergraduate education at Lincoln University. Of the nine graduates, two are in medical school, seven are in graduate school, and one currently working and applying to graduate schools., The original document contains color images.

The purpose of the research supported by this award is to conduct a Phase II clinical trial (study) of an adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols have been used in the trial: #1 - Phase II study of Adenovirus/PSA vaccine in men with recurrent prostate cancer after local therapy; and #2 - Phase II study of Adenovirus/PSA vaccine in men with hormone refractory prostate cancer. In the first protocol men with newly recurrent prostate cancer were randomized to one of two arms of the study. Patients in Arm A received the Ad/PSA vaccine only; three injections spaced 30 days apart. Patients in Arm B received androgen deprivation therapy (ADT) followed at day 14 by the Ad/PSA vaccine, again with three injections. In the second protocol men with hormone refractory prostate cancer were injected with the vaccine only, three injections 30 days apart. The patients were followed for toxicity, the development of anti-PSA immune responses, and evidence of a clinical effect of the vaccination. The latter includes changes in serum PSA and prostatic acid phosphatase (PAP) levels and in the PSA doubling times (PSADT). Patients in protocol #2 also have CT and bone scans to monitor their prostate cancer.

The HBCU Summer Research Training Program accepted a total of eight students from Lincoln University for the eight week session in the summer of 2007. Five of the students were supported by this grant and three of the students were supported by the second grant awarded in 2007. At the last minute one student withdrew leaving seven students for the summer. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor's laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conference at Purdue University. At the end of the summer session the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University and some presented at the DOD's IMPaCT meeting in the Fall of 2007. Of the seven students, three have graduated and four are in their junior year at Lincoln University. Of the three graduates, two are in graduate school and one currently working and applying to graduate schools., The original document contains color images.

The purpose of the research supported by this award is to conduct a Phase II clinical trial (study) of an adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols will be used in the trial: #1 - Phase II study of Adenovirus/PSA vaccine in men with recurrent prostate cancer after local therapy; and #2 - Phase II study of Adenovirus/PSA vaccine in men with hormone refractory prostate cancer. In the first protocol men with newly recurrent prostate cancer will be randomized to one of two arms of the study. Patients in Arm A will receive the Ad/PSA vaccine only; three injections spaced 30 days apart. Patients in Arm B will receive androgen deprivation therapy (ADT) followed at day 14 by the Ad/PSA vaccine, again with three injections. In the second protocol men with hormone refractory prostate cancer will be injected with the vaccine only, three injections 30 days apart. The patients will be followed for toxicity, the development of anti-PSA immune responses, and evidence of a clinical effect of the vaccination. The latter includes changes in serum PSA levels and in the PSA doubling times (PSADT). Patients in protocol #2 will also have CT and bone scans to monitor their prostate cancer.

We have successfully submitted clinical trial documents to regulatory agencies following a long interaction with the DOD following their approval of a three year clinical trial award.. We have received an exemption from the RAC and are awaiting final approval by the DOD s HSRRB, the University of Iowa s IRB, and the FDA., The original document contains color images.

The HBCU Summer Research Training Program accepted six students from Lincoln University for the eight week session in the summer of 2006. Five of the students were supported by the DOD grant and an additional student was supported by a collaborating faculty member at the University of Iowa. Each student was assigned to a laboratory of a participating mentor and also paired with a member of the mentor's laboratory. This laboratory member assisted with day to day aspects of the research project. During the summer the students worked diligently on their research project, participated in meetings of the mentor's laboratory, attended workshops and seminars associated with our and other summer programs, and attended a special course in prostate cancer. We integrated the Lincoln students into social programs held throughout the campus for summer interns and they attended and participated in the CIC Conference at the University of Illinois. At the end of the summer session the students presented a poster of the research results from the summer experience. They also presented the results of their research in the fall at Lincoln University and many presented at a national meeting in Florida during the fall/winter of 2006. All of the students have applied to graduate programs for the fall of 2007., The original document contains color images.

The goal of this Clinical Trial Developmental Award (CTDA) was to develop and complete the required administrative tasks necessary to begin a Phase II clinical trial of an adenovirus/PSA (Ad/PSA) vaccine in men with recurrent prostate cancer and a Phase I clinical trial of the combination of the Ad/PSA vaccine along with immunostimulatory CpG ODN. The tasks included the design and construction of the clinical protocols, informed consent forms, submission to the institutional committees that include the Protocol Review and Monitoring Committee, Human Subjects Committee (IRB), Biosafety Committee, Pharmacy and Therapeutics Committee; the NIH Recombinant DNA Advisory Committee (RAC), and the food and Drug Administration (FDA). In addition, although not funded by the CTDA, we were required by the FDA to perform Pharmacology/Toxicology and Histopathology Studies and to obtain a complete DNA sequence of the Ad/PSA vaccine., The original document contains color images.