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Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors
Sponsor: National Cancer Institute (NCI)
Summary
This phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotatate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving triapine in combination with lutetium Lu 177 dotatate may be more effective at shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone.
Official title: A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2023-08-30
Completion Date
2026-12-09
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Lutetium Lu 177 Dotatate
Given IV
Magnetic Resonance Imaging
Undergo MRI
Triapine
Given PO
Locations (25)
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
MD Anderson in The Woodlands
Conroe, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States