The primary objective of this study is:
¿ To characterize the safety and tolerability of DKN-01 in combination with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or extra-hepatic biliary system or gallbladder.
The secondary objectives of this study are:
¿ To estimate the overall response rate (ORR), progression free survival (PFS), duration of response (DoR), and overall survival (OS)of patients with carcinoma primary to the intra- or extra-hepatic biliary system or gallbladder treated with DKN-01 in combination with gemcitabine and cisplatin.
¿ To characterize the pharmacokinetics of DKN-01 in combination with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder.
Study of the Genetic Epidemiology of Childhood Cancer
Dr. Christine Aguilar
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the EAU guidelines and the "control" refers to surveillance based on the AUA guidelines.
Research methods: Participants who presents with non-muscle invasive bladder cancer and meets the inclusion/exclusion criteria will be given an option to participate in the study. Participants will be enrolled at the Urology Clinics at the University of Texas Health Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas Veterans Health Care System (STVHCS). Non-local site include the University of Texas Southwestern Medical Center (UTSW). The research procedures consist of urine collection, cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by the tumor recurrence and progression of the disease. At various time points throughout the study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed consent. The urine is de-identified in the lab per the Health Insurance Portability and Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) # 20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again at 24 months following the diagnosis of bladder cancer. Patients randomized to the control arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis of bladder cancer. Because use of cytology is variable among the participating urologist, the utilization of cytology will be at the treating urologist's discretion as per usual standard care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the surveillance schedule based on the length of time from their last tumor.
The study is designed to investigate whether eflornithine, sulindac or both are effective in preventing or delaying adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.
The primary objective is to assess whether eflornithine and/or sulindac are effective in reducing the recurrence rate at 3 years.
The study will enroll approximately 1340 participants from hundreds of cancer centers in the US.
In addition to other conditions for enrollment, eligible patients have a history of stage 0-III colon cancer that was surgically removed up to 1 year previously; rectosigmoid cancers are eligible if no prior radiation therapy, no evidence of cancer by colonoscopy exam at time of study entry, and able to take oral medications.
Patients who have a history of uncontrolled hypertension or gastric/duodenal ulcer within past year or other medical conditions may not be eligible to enroll.
This study is designed as a cross sectional, exploratory pilot study to examine the onset and progression of cancer-related fatigue in prostate cancer patients. The goal of this project is to report the effect of fatigue on quality of life and pilot a novel salivary biomarker to measure fatigue. One hundred men,diagnosed with prostate cancer and 200 men without prostate cancer will be recruited to participate in this study. Detailed medical and medication history will be reviewed to determine if subjects are eligible to participate in this study.All eligible participants will be recruited to participate in this study. All activities will be done during the patients regularly schedule visit with their oncologist at the CTRC. Each subject will sign an informed consent form indicating their willingness to participate afterwhich they will complete a battery of survey instruments and provide a 4 mL saliva sample. Saliva will be used to assess concentrations of a fatigue biomarkers in this study and banked for future research studies. Total length of time for study participation for each subject should be less than 1 hour.
Darpan Patel, Ph.D.