Spots Global Cancer Trial Database for Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
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Trial Identification
Brief Title: Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
Official Title: A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer
Study ID: NCT01507545
Study Description
Brief Summary: The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.
Detailed Description: Tumor endothelial marker-1 also referred to as TEM-1 is expressed in the supportive tissue, as well as, on the cells within the tumor. TEM-1, which is a cell surface glycoprotein, and is expressed in the stromal compartment (cells) of nearly all human tumors. In preclinical studies, it has been shown that TEM-1 plays a key role in tumor growth and the vascularization of tumors. There is evidence suggesting an association between the level of TEM-1, 7, 7R, 8 in relation to lymph node involvement and disease progression. MORAb-004 is a humanized immunoglobulin G (IgG1/κ) antibody directed against endosialin/TEM-1. Nonclinical pharmacological studies showed that MORAb-004 has the ability to block specific TEM-1 receptor-ligand interactions. Immunohistochemistry studies of human tumor biopsy samples demonstrate TEM-1 expression and MORAb-004 binding to tumor stromal cells, in particular mural cell compartment of neovessels and cancer-associated fibroblasts. All of which suggests a potential effective treatment. Researchers hypothesize that an antibody therapy that binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical study is a proof of concept study to see if an anti-TEM-1 agent is safe and effective in the treatment of metastatic, colorectal cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Central Hem/Onc Medical Group, Inc., Alhambra, California, United States
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Providence St. Joseph Medical Center-Disney Family Cancer Center, Burbank, California, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center, Northridge, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Sharp Memorial Hospital, San Diego, California, United States
CPMCRI / Pacific Hematology Oncology Associates, San Francisco, California, United States
Central Coast Medical Oncology, Santa Maria, California, United States
UCLA Hematology Oncology, Santa Monica, California, United States
Colorado Cancer Research Program, Denver, Colorado, United States
St. Mary's Hospital Regional Cancer Center, Grand Junction, Colorado, United States
Lutheran Hematology & Oncology, Wheat Ridge, Colorado, United States
Christiana Care Health Services, Newark, Delaware, United States
Georgetown University, Washington, District of Columbia, United States
Mayo Clinic Florida Hematology/Oncology, Jacksonville, Florida, United States
Integrated Community Oncology Network / Cancer Specialists of North Florida, Jacksonville, Florida, United States
Compass Research, LLC, Orange City, Florida, United States
Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
Cancer Care Centers of Brevard, Rockledge, Florida, United States
H. Lee Moffitt Cancer Center (Moffitt Cancer Center), Tampa, Florida, United States
Suburban Hematology-Oncology Associates, P.C., Duluth, Georgia, United States
Suburban Hematology-Oncology Assoc., PC, Lawrenceville, Georgia, United States
Suburban Hematology-Oncology Associates, P.C., Snellville, Georgia, United States
Medical and Surgical Specialists, Galesburg, Illinois, United States
Ingalls Cancer Research Center, Harvey, Illinois, United States
Oncology Specialists,S.C. Center for Advanced Care, Park Ridge, Illinois, United States
Illinois CancerCare, P.C., Peoria, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Medical Oncology & Hematology Associates (Clinic #3), Clive, Iowa, United States
Iowa Oncology Research Association, Des Moines, Iowa, United States
Medical Oncology & Hematology Associates (Clinic #1), Des Moines, Iowa, United States
Medical Oncology & Hematology Associates (Clinic #2), Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Central Baptist Hospital, Lexington, Kentucky, United States
John Hopkins University, Baltimore, Maryland, United States
Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland, United States
Lahey Clinic, Burlington, Massachusetts, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
Essentia Health Duluth CCOP, Duluth, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Coborn Cancer Center/ CentraCare Health Plaza, Saint Cloud, Minnesota, United States
Metro Minnesota CCOP, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Louis Park, Minnesota, United States
St. John's Hospital, Saint Louis Park, Minnesota, United States
CCCN, Las Vegas, Nevada, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Mount Sinai Medical Center, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Presbyterian Hospital Cancer Center, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Piedmont Hematology Oncology Associates PA, Winston-Salem, North Carolina, United States
Medcenter One, Bismarck, North Dakota, United States
TriHealth Oncology Institute/Oncology Partners Network, Cincinnati, Ohio, United States
Hickman Cancer Center at Flower Hospital, Sylvania, Ohio, United States
Mercy Cancer Center, Toledo, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Pharma Resource, East Providence, Rhode Island, United States
Rhode Island Hospital, Providence, Rhode Island, United States
The Miriam Hospital, Providence, Rhode Island, United States
St. Vincent Hospital / Green Bay Oncology, Green Bay, Wisconsin, United States
St. Mary's Hospital / Green Bay Oncology, Green Bay, Wisconsin, United States
Contact Details
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