Spots Global Cancer Trial Database for Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
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Trial Identification
Brief Title: Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
Official Title: A Phase II Study of Bevacizumab Alone or in Combination With TRC105 for Advanced Renal Cell Cancer
Study ID: NCT01727089
Study Description
Brief Summary: This randomized phase II trial studies how well bevacizumab with or without anti-endoglin monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by targeting certain cells.
Detailed Description: PRIMARY OBJECTIVES: I. To compare the progression-free survival at 12 and 24 weeks for bevacizumab alone or in combination with TRC105 (anti-endoglin monoclonal antibody TRC105). SECONDARY OBJECTIVES: I. Toxicity and Response Evaluation Criteria in Solid Tumors (RECIST) response rate for the combination compared to single agent bevacizumab. TERTIARY OBJECTIVES: I. To evaluate tumor tissue expression of endoglin (CD105), transforming growth factor, beta receptor II (TGFBR2), activin A receptor type II-like 1 (ACVRL1) and transforming growth factor, beta receptor 1 (TGFBR1) kinase from pre- and post-treatment tissue samples in order to determine whether CD105 and stem cell activation occurs after exposure to anti-vascular endothelial growth factor (VEGF) therapy as predicted by laboratory models, and whether exposure to anti-endoglin monoclonal antibody TRC105 affects these changes. II. To compare the soluble CD105 levels at baseline and after treatment between the group receiving bevacizumab alone and the group receiving bevacizumab in combination with anti-endoglin monoclonal antibody TRC105. III. To compare TGFBR2 levels at baseline and after treatment between the group receiving bevacizumab alone and the group receiving bevacizumab in combination with anti-endoglin monoclonal antibody TRC105. IV. To evaluate whether circulating tumor cells (CTCs) can be detected in this patient population using parylene membrane filter technology, and whether changes in CTC counts and CD105 expression on CTCs during therapy correspond to imaging and clinical response. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15. ARM II: Patients receive bevacizumab as in Arm I and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 1, 8, 15, and 22. In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up for 4 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
University of Colorado, Denver, Colorado, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard, Fort Wayne, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Tanya Dorff
Affiliation: City of Hope Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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