Spots Global Cancer Trial Database for Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
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Trial Identification
Brief Title: Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
Official Title: A Phase II Study of the Peroxisome Proliferator-Activated Receptor Gamma Agonist, Efatutazone in Patients With Previously Treated, Unresectable Myxoid Liposarcoma
Study ID: NCT02249949
Conditions
Interventions
Study Description
Brief Summary: This phase II trial studies how well efatutazone dihydrochloride works in treating patients with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in chemotherapy, such as efatutazone dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the confirmed response rate for efatutazone dihydrochloride (efatutazone) in patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy. SECONDARY OBJECTIVES: I. To assess the progression free survival (PFS), overall survival (OS), and adverse event rates for efatutazone treated patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy. TERTIARY OBJECTIVES: I. To assess the predictive value of peroxisome proliferator-activated receptor (PPAR) and retinoid X receptors (RXR) tumor expression from archived patient tumor samples. II. To assess the predictive value of the expression of PPARgamma-regulated markers of adipocytes differentiation. III. To assess the predictive value of the expression of PPARgamma-regulated cell cycle proteins. IV. To assess the effects of efatutazone treatment on serum adiponectin levels. OUTLINE: Patients receive efatutazone dihydrochloride orally (PO) twice daily (BID) continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 6 months for up to 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of Colorado Hospital, Aurora, Colorado, United States
Yale University, New Haven, Connecticut, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Northside Hospital, Atlanta, Georgia, United States
Northside Hospital-Forsyth, Cumming, Georgia, United States
Hawaii Oncology Inc-Pali Momi, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc-POB II, Honolulu, Hawaii, United States
Hawaii Oncology Inc-POB I, Honolulu, Hawaii, United States
Island Urology, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini, Honolulu, Hawaii, United States
Kuakini Medical Center, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Memorial Hospital of Carbondale, Carbondale, Illinois, United States
SIH Cancer Institute, Carterville, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Carle on Vermilion, Danville, Illinois, United States
Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Radiation Oncology of Northern Illinois, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea, Swansea, Illinois, United States
Memorial and Saint Elizabeth's Health Care Services LLP, Swansea, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Rush-Copley Healthcare Center, Yorkville, Illinois, United States
Deaconess Clinic Downtown, Evansville, Indiana, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States
Woodland Cancer Care Center, Michigan City, Indiana, United States
Chancellor Center for Oncology, Newburgh, Indiana, United States
Kansas Institute of Medicine Cancer and Blood Center, Lenexa, Kansas, United States
Minimally Invasive Surgery Hospital, Lenexa, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Saint Luke's South Hospital, Overland Park, Kansas, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States
Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States
Cox Cancer Center Branson, Branson, Missouri, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
Capital Region Southwest Campus, Jefferson City, Missouri, United States
Freeman Health System, Joplin, Missouri, United States
Mercy Hospital Joplin, Joplin, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, United States
Mercy Hospital Washington, Washington, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Norris Cotton Cancer Center-Manchester, Manchester, New Hampshire, United States
Norris Cotton Cancer Center-Nashua, Nashua, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University/Herbert Irving Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Integris Southwest Medical Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
Integris Cancer Institute of Oklahoma, Oklahoma City, Oklahoma, United States
Greenville Health System Cancer Institute-Easley, Easley, South Carolina, United States
Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Greenville Memorial Hospital, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer, Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Contact Details
Name: Michael Pishvaian, MD, PhD
Affiliation: Georgetown University
Role: STUDY_CHAIR
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