Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03778879
Status:
WITHDRAWN
Last Update Posted:
2019-07-19
First Post:
2018-12-15
Brief Title:
Pre-operative Stereotactic Body Radiation Therapy for Pancreatic Adenocarcinoma With or Without CCX872-B
Sponsor:
Alan Katz
Organization:
University of Rochester
Study Overview
Official Title:
A Phase 1b Trial of Neoadjuvant Stereotactic Body Radiotherapy With or Without CCR2 Inhibitor CCX872-B Immunotherapy for Preoperative Treatment of Resectable Pancreatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CCX872-B will not be available in sufficient quantity to conduct the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Standard treatment for newly diagnosed operable pancreatic cancer usually involves undergoing surgery first and then receiving chemotherapy with or without radiation therapy However the pancreatic cancer often comes back after this treatment Therefore the investigators are studying whether giving treatment prior to surgery can help decrease the risk the cancer returns
Stereotactic Body Radiation Therapy SBRT is a highly focused type of radiation therapy commonly used in the treatment of pancreatic cancer This treatment has been shown to be safe and effective for the preoperative treatment of pancreatic cancer The purpose of this study is to determine if combining an experimental drug CCX872-B with SBRT continues to be safe and whether the combination treatment may be more effective at boosting the participants immune systems ability to kill the pancreatic cancer
Stereotactic Body Radiation Therapy SBRT is a highly focused type of radiation therapy commonly used in the treatment of pancreatic cancer This treatment has been shown to be safe and effective for the preoperative treatment of pancreatic cancer The purpose of this study is to determine if combining an experimental drug CCX872-B with SBRT continues to be safe and whether the combination treatment may be more effective at boosting the participants immune systems ability to kill the pancreatic cancer
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None