A Phase II Study Of hu14.18-IL2 In Children With Recurrent Or Refractory Neuroblastoma
OBJECTIVES:
- Determine the response rate in children with recurrent or refractory neuroblastoma
treated with hu14.18-interleukin-2 (hu14.18-IL2) fusion protein.
- Determine the adverse events of this drug in these patients.
- Determine the immunologic activation in patients treated with this drug.
- Determine the induction of anti-hu14.18-IL2 antibody in patients treated with this
drug.
- Correlate antitumor response with measurements of toxicity, immune activation, and
anti-hu14.18-IL2 antibody activity in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to
measurable/evaluable disease (measurable by standard radiographic criteria vs evaluable by
MIBG scanning and/or bone marrow histology vs disease identified and quantified by bone
marrow immunohistochemistry).
Patients will be enrolled in 3 strata, and evaluated for antitumor response following 2
monthly courses (treatment on Days 1-3, followed by 25 days of observation,). Patients with
progressive disease will be taken off protocol therapy. Patients with stabilization or
regression of disease will be eligible to receive 2 more monthly courses of treatment.
Additional treatment following course 4 will be allowed for patients showing a continued
clinical response, up to a maximum of 10 courses of treatment.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40-60 patients (20 for strata 1 and 2 and 0-20 for stratum 3)
will be accrued for this study within 2 years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best overall response (complete response, very good partial response, or partial response)
Proportion of responders within each stratum. Patients deemed inevaluable for response will have available response data tabulated and reported descriptively, but will not be counted in the target accrual for response for each strata. Stratum 03 patients will not be included in the statistical analysis to determine activity of hu14.18-IL2, since there is not sufficient data to support the significance of immunocytologic responses. Such responses will be tabulated and reported
Up to 30 weeks
No
Paul M Sondel, MD, PhD
Study Chair
University of Wisconsin, Madison
United States: Federal Government
ANBL0322
NCT00082758
August 2005
May 2012
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
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 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
New York Medical College | Valhalla, New York 10595 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Sutter Cancer Center | Sacramento, California 95816 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Children's Hospital Central California | Madera, California 93638-8762 |
Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
CancerCare of Maine at Eastern Maine Medial Center | Bangor, Maine 04401 |
Floating Hospital for Children at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo, Texas 79106 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Carilion Cancer Center of Western Virginia | Roanoke, Virginia 24029 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
Children's Hospital Cancer Center | Denver, Colorado 80218 |
Columbus Children's Hospital | Columbus, Ohio 43205-2696 |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
Stanford Comprehensive Cancer Center - Stanford | Stanford, California 94305 |
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
T.C. Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
University of Minnesota Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |