A Randomized Phase II Trial of Bevacizumab (IND# 7921, Avastin) and Temsirolimus (IND# 61010, Torisel) in Combination With Intravenous Vinorelbine and Cyclophosphamide in Patients With Recurrent/Refractory Rhabdomyosarcoma
PRIMARY OBJECTIVES:
l. To determine the feasibility of administering bevacizumab in combination with intravenous
vinorelbine and cyclophosphamide (VC) in patients with recurrent rhabdomyosarcoma (RMS).
II. To determine the feasibility of administering temsirolimus in combination with VC in
patients with recurrent RMS.
III. To estimate the event-free survival (EFS) of patients with recurrent/refractory RMS
treated with bevacizumab and VC and compare with the EFS of those treated with temsirolimus
and VC.
SECONDARY OBJECTIVES:
I. To estimate the initial (2 cycle) response rate of patients with recurrent/refractory RMS
treated with bevacizumab and VC and compare with the response rate of those treated with
temsirolimus and VC, and to also compare the best response rate on each regimen of protocol
therapy.
II. To evaluate surrogate biological markers in patients with recurrent RMS and to estimate
differences in these markers following treatment with bevacizumab and temsirolimus.
OUTLINE: This is a multicenter study. Patients are stratified according to histologic sub
type at initial diagnosis. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes on days 1
and 8 and cyclophosphamide IV over 30-60 minutes on day 1. Patients also receive bevacizumab
IV over 30-90 minutes on day 1.
ARM II: Patients receive vinorelbine tartrate and cyclophosphamide as in arm I. Patients
also receive temsirolimus IV over 30-60 minutes on days 1, 8, and 15.
In both arms, treatment repeats every 21 days for 12 courses in the absence of disease
progression or unacceptable toxicity. Blood and tissue samples may be collected for
correlative studies.
After completion of study treatment, patients are followed up annually for 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free survival
Estimated using Kaplan-Meier curves. EFS experience for the 2 regimens will be compared using the log-rank test.
From enrollment to the first occurrence of disease recurrence or death from any cause, up to 5 years
No
Leo Mascarenhas
Principal Investigator
Children's Oncology Group
United States: Food and Drug Administration
NCI-2011-02607
NCT01222715
October 2010
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Johns Hopkins University | Baltimore, Maryland 21205 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
New York Medical College | Valhalla, New York 10595 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Winthrop University Hospital | Mineola, New York 11501 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
Dell Children's Medical Center of Central Texas | Austin, Texas 78723 |
Children's Hospital and Research Center at Oakland | Oakland, California 94609-1809 |
Mary Bridge Children's Hospital and Health Center | Tacoma, Washington 98415-0299 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
City of Hope | Duarte, California 91010 |
Lee Memorial Health System | Fort Myers, Florida 33902 |
University of Virginia | Charlottesville, Virginia 22908 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Children's Hospital of Alabama | Birmingham, Alabama 35233 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Rochester | Rochester, New York 14642 |
Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids, Michigan 49503 |
Yale University | New Haven, Connecticut 06520 |
Wayne State University | Detroit, Michigan 48202 |
Mercy Children's Hospital | Toledo, Ohio 43608 |
Legacy Emanuel Children's Hospital | Portland, Oregon 97227 |
BI-LO Charities Children's Cancer Center | Greenville, South Carolina 29605 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University Of Vermont | Burlington,, Vermont 05403 |
Albany Medical Center | Albany, New York 12208 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Oregon Health and Science University | Portland, Oregon 97201 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
Virginia Commonwealth University | Richmond, Virginia |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Childrens Memorial Hospital | Chicago, Illinois 60614 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Luke's Mountain States Tumor Institute | Boise, Idaho 83712 |
Saint Vincent Hospital and Health Services | Indianapolis, Indiana 46260 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Michigan State University - Breslin Cancer Center | East Lansing, Michigan 48824-1313 |
Kalamazoo Center for Medical Studies | Kalamazoo, Michigan 49008 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
New York University Langone Medical Center | New York, New York 10016 |
Columbia University Medical Center | New York, New York 10032 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Mission Hospitals Inc | Asheville, North Carolina 28801 |
Natalie W Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
University of Illinois | Chicago, Illinois 60612 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood, Florida 33021 |
West Virginia University Charleston | Charleston, West Virginia 25304 |
The Children's Medical Center of Dayton | Dayton, Ohio 45404 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
University of Minnesota Medical Center-Fairview | Minneapolis, Minnesota 55455 |
C S Mott Children's Hospital | Ann Arbor, Michigan 48109 |
Southern Illinois University | Springfield, Illinois 62702 |
University Of Missouri-Columbia | Columbia, Missouri 65212 |
Walter Reed National Military Medical Center | Bethesda, Maryland 20889 |
Riley Hospital for Children | Indianapolis, Indiana 46202 |
Cardinal Glennon Children's Medical Center | St. Louis, Missouri 63104 |
UMDNJ - Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Miller Children's Hospital | Long Beach, California 90806 |
Childrens Hospital of Orange County | Orange, California 92868-3874 |
Alfred I duPont Hospital for Children | Wilmington, Delaware 19803 |
Nemours Children's Clinic - Jacksonville | Jacksonville, Florida 32207-8426 |
Nemours Childrens Clinic - Orlando | Orlando, Florida 32806 |
Saint Joseph Children's Hospital of Tampa | Tampa, Florida 33607 |
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia 30322 |
The Childrens Mercy Hospital | Kansas City, Missouri 64108 |
Rainbow Babies and Childrens Hospital | Cleveland, Ohio 44106 |
Penn State Hershey Children's Hospital | Hershey, Pennsylvania 17033 |
Palmetto Health Richland | Columbia, South Carolina 29203 |
East Tennessee Childrens Hospital | Knoxville, Tennessee 37916 |
Saint Mary's Hospital | West Palm Beach, Florida 33407 |
Children's Hospital and Medical Center of Omaha | Omaha, Nebraska 68114 |
Saint Joseph's Regional Medical Center | Paterson, New Jersey 07503 |
Texas Tech University Health Science Center-Amarillo | Amarillo, Texas 79106 |
Childrens Hospital-King's Daughters | Norfolk, Virginia 23507 |
Sanford Medical Center-Fargo | Fargo, North Dakota 58122 |
Children's Hospital Colorado | Aurora, Colorado 80045 |
Floating Hospital for Children at Tufts Medical Center | Boston, Massachusetts 02111 |
Lucile Packard Children's Hospital Stanford University | Palo Alto, California 94304 |
University of California San Francisco Medical Center-Parnassus | San Francisco, California 94143 |
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver, Colorado 80218 |
Raymond Blank Children's Hospital | Des Moines, Iowa 50309 |
Children's Hospital-Main Campus | New Orleans, Louisiana 70118 |
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio 43606 |
Greenville Cancer Treatment Center | Greenville, South Carolina 29605 |
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota 57117-5134 |
T C Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington 99204 |
The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park, New York 11040 |