A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND #100947, NSC #742460) in Children With Relapsed/Refractory Solid Tumors
PRIMARY OBJECTIVES:
I. To determine the response rate to IMC-A12 (cixutumumab) administered in various strata of
recurrent/refractory malignant solid tumors in childhood and young adulthood.
II. To further define and describe the toxicities of IMC-A12. III. To further characterize
the pharmacokinetics of IMC-A12.
SECONDARY OBJECTIVES:
I. To examine the relationship between tumor expression of IGF-I, IGF-II, and IGF-IR and
response to IMC-A12.
II. To determine the human anti-human antibody (HAHA) response after treatment with IMC-A12.
III. To further evaluate the effect of IMC-A12 on circulating levels of proteins involved in
linear growth and glucose homeostasis, including IGF-I, IGF-II, IGF-BP3, growth hormone,
insulin, and C-peptide.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type.
Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, 15, and 22.
Treatment repeats every 28 days for up to 24 courses in the absence of disease progression
or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative laboratory studies.
Samples are analyzed for IGF-I, IGF-II, IGF-BP3, growth hormone, insulin, and C-peptide
levels and for immunogenicity.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
Response rates will be calculated as the percent of patients whose best response is a CR or PR, and the 95% confidence intervals will be constructed according to the method of Chang.
24 weeks
No
Brenda Weigel
Principal Investigator
Children's Oncology Group
United States: Food and Drug Administration
NCI-2009-01170
NCT00831844
January 2009
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Mayo Clinic | Rochester, Minnesota 55905 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
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 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
New York Medical College | Valhalla, New York 10595 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
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 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
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 |
Mary Bridge Children's Hospital and Health Center | Tacoma, Washington 98415-0299 |
Lehigh Valley Hospital - Muhlenberg | Bethlehem, Pennsylvania 18017 |
Lee Memorial Health System | Fort Myers, Florida 33902 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
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 |
Wayne State University | Detroit, Michigan 48202 |
Albany Medical Center | Albany, New York 12208 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Oregon Health and Science University | Portland, Oregon 97201 |
Virginia Commonwealth University | Richmond, Virginia |
Florida Hospital | Orlando, Florida 32803 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Childrens Memorial Hospital | Chicago, Illinois 60614 |
Kaiser Permanente-Oakland | Oakland, California 94611 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
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 John Hospital and Medical Center | Detroit, Michigan 48236 |
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 |
University of Illinois | Chicago, Illinois 60612 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
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 |
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 |
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 |
Texas Tech University Health Science Center-Amarillo | Amarillo, Texas 79106 |
Childrens Hospital-King's Daughters | Norfolk, Virginia 23507 |
Lucile Packard Children's Hospital Stanford University | Palo Alto, California 94304 |
University of California San Francisco Medical Center-Parnassus | San Francisco, California 94143 |
Greenville Cancer Treatment Center | Greenville, South Carolina 29605 |
T C Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington 99204 |