Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alan Katz
The investigators have shown that preoperative SBRT followed by surgical resection is feasible and safe in patients in the previous trial UGIP14107. The investigators have also presented preclinical evidence that inhibiting entry of CCR2+ IM using a small molecule antagonist against CCR2 results in enhanced efficacy of RT 26. The investigators hypothesize that inhibition of the CCR2 axis can potentially up regulate the immune response following radiation, therefore leading to a more robust tumor killing response. In preclinical studies, CCR2 inhibitor has little effect in the absence of RT, therefore, the investigators are not including a drug therapy alone group. To test this hypothesis, a phase Ib clinical trial has been proposed to evaluate the effect of combining stereotactic body radiotherapy with CCR2 inhibition in the neoadjuvant treatment of surgically resectable adenocarcinoma of the head of the pancreas. The study will consist of two parts in sequential fashion. The first fifteen patients will be assigned to Group 1 and undergo SBRT with CCR2 inhibitor CCX872-B. The primary objective is to establish safety and feasibility of the treatment and analyze biomarkers to determine if combined treatment can stimulate an immune response in human patients. A second group of 5 patients will undergo SBRT alone as a comparison group for biomarker immune response. The investigators would like to proceed with SBRT and CCX872-B as Group 1 given the investigators already have sufficient data from UGIP14107 to show that SBRT is safe and feasible and studying the combination of SBRT with CCX872-B is the primary scientific objective of this study. If unexpected safety issues occur with Group 1, the investigators would consider closing trial at that time without enrolling any patients in Group 2 which would reduce the number of patients exposed to the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
