Spots Global Cancer Trial Database for Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
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Trial Identification
Brief Title: Alisertib in Treating Patients With Advanced or Metastatic Sarcoma
Official Title: Phase II Study of MLN8237 in Advanced/Metastatic Sarcoma
Study ID: NCT01653028
Study Description
Brief Summary: This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the response rate (complete response \[CR\] + partial response \[PR\]) assessed for patients within each cohort: liposarcoma (cohort 1); leiomyosarcoma (non-uterine) (cohort 2); undifferentiated sarcoma (including pleomorphic undifferentiated sarcoma, formerly known as malignant fibrous histiocytoma, and myxofibrosarcoma) (cohort 3); malignant peripheral nerve sheath tumor (cohort 4); and other sarcomas (cohort 5). SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) and overall survival (OS) for patients treated with MLN8237 (alisertib) in each cohort. II. To assess the adverse events associated with patients treated with MLN8237 in each cohort. TERTIARY OBJECTIVES: I. To correlate potential clinical benefit with markers of aurora kinase inhibition in pre- and post-treatment tumor biopsies. II. To correlate clinical outcome with change in fluorine F 18 fluorothymidine (FLT)-positron emission tomography (PET) uptake at baseline versus after one week of treatment (ie, week 2 of cycle 1). OUTLINE: Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 18 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
The Medical Center of Aurora, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, United States
SCL Health Saint Joseph Hospital, Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Colorado Cancer Research Program NCORP, Denver, Colorado, United States
Mercy Medical Center, Durango, Colorado, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC, Englewood, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Mountain Blue Cancer Care Center, Golden, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Rocky Mountain Cancer Centers-Greenwood Village, Greenwood Village, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker, Parker, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Pueblo, Pueblo, Colorado, United States
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
John B Amos Cancer Center, Columbus, Georgia, United States
Hawaii Oncology Inc-Pali Momi, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc-POB II, 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
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Castle Medical Center, Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
Northwestern University, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States
Spector, David MD (UIA Investigator), Moline, Illinois, United States
Trinity Medical Center, Moline, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Reid Health, Richmond, Indiana, United States
Mary Greeley Medical Center, Ames, Iowa, United States
McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
McFarland Clinic PC-Boone, Boone, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Mercy Cancer Center-West Lakes, Clive, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
McFarland Clinic PC-Jefferson, Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown, Marshalltown, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Saint Luke's South Hospital, Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Oncology Hematology Care Inc-Crestview, Crestview Hills, Kentucky, United States
Boston Medical Center, Boston, Massachusetts, United States
Bixby Medical Center, Adrian, Michigan, United States
Hickman Cancer Center, Adrian, Michigan, United States
Green Bay Oncology - Escanaba, Escanaba, Michigan, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Mercy Memorial Hospital, Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe, Monroe, Michigan, United States
Sanford Clinic North-Bemidgi, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
North Kansas City Hospital, Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated, 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
Liberty Radiation Oncology Center, Liberty, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc, Saint Joseph, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Montana Cancer Consortium NCORP, Billings, Montana, United States
Saint Vincent Frontier Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Montana Cancer Specialists, Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
CHI Health Saint Francis, Grand Island, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Rockville Centre, Rockville Centre, New York, United States
Memorial Sloan Kettering Sleepy Hollow, Sleepy Hollow, New York, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
Iredell Memorial Hospital, Statesville, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, United States
Roger Maris Cancer Center, Fargo, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Clinic North-Fargo, Fargo, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green, Bowling Green, Ohio, United States
Oncology Hematology Care Inc-Eden Park, Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Mercy West, Cincinnati, Ohio, United States
Oncology Hematology Care Inc - Anderson, Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, United States
Oncology Hematology Care Inc-Blue Ash, Cincinnati, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Health Center, Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program, Dayton, Ohio, United States
Hematology Oncology Center Incorporated, Elyria, Ohio, United States
Mercy Cancer Center-Elyria, Elyria, Ohio, United States
Oncology Hematology Care Inc-Healthplex, Fairfield, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center, Maumee, Ohio, United States
Saint Charles Hospital, Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon, Oregon, Ohio, United States
Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
Saint Vincent Mercy Medical Center, Toledo, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States
Mercy Saint Anne Hospital, Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Wright-Patterson Medical Center, Wright-Patterson Air Force Base, Ohio, United States
Greene Memorial Hospital, Xenia, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States
Warren Clinic Oncology-Tulsa, Tulsa, Oklahoma, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Geisinger Medical Oncology-Pottsville, Pottsville, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Sanford Cancer Center-Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States
University of Vermont College of Medicine, Burlington, Vermont, United States
Fredericksburg Oncology Inc, Fredericksburg, Virginia, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin, United States
HSHS Saint Nicholas Hospital, Sheboygan, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Rocky Mountain Oncology, Casper, Wyoming, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: Mark Dickson
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR
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