A Phase II Study of Irinotecan + Temozolomide in Children With Recurrent Neuroblastoma
OBJECTIVES:
Primary
- Determine the response rate in pediatric patients with relapsed neuroblastoma (NB)
treated with irinotecan hydrochloride and temozolomide.
- Determine the toxicities associated with irinotecan and temozolomide in patients
treated with this regimen.
Secondary
- Evaluate the impact of p53 loss of function on response rate and event-free survival
from start of relapse therapy.
- Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients.
- Collect and bank serum and nucleic acid specimen to facilitate future biomarker
studies.
- Evaluate the feasibility of collecting blood samples on a group wide basis for
assessment of changes in circulating markers of angiogenesis.
- Assess, preliminarily, the effects of irinotecan hydrochloride and temozolomide on
circulating markers of angiogenesis.
OUTLINE: This is a multicenter study.
Patients are stratified according to disease status (measurable disease [measured by
conventional CT scan and/or MRI] vs evaluable disease [tumor detected by conventional
morphologic analysis of bone marrow aspirate/biopsy AND/OR abnormal uptake at ≥ 1 site on
MIBG scan]).
Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral
temozolomide on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Overall response (complete and partial response)
No
Rochelle Bagatell, MD
Study Chair
University of Arizona
United States: Federal Government
CDR0000465487
NCT00311584
April 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Hurley Medical Center | Flint, Michigan 48503 |
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 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
New York Medical College | Valhalla, New York 10595 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
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 Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
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 |
Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
Children's Medical Center - Dayton | Dayton, Ohio 45404 |
Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
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 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Blank Children's Hospital | Des Moines, Iowa 50309 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
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 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Children's Hospital and Research Center Oakland | Oakland, California 94609 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Children's Hospital Center for Cancer and Blood Disorders | Aurora, Colorado 80045 |
Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Children's Hospital | Omaha, Nebraska 68114-4113 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Maimonides Cancer Center at Maimonides Medical Center | Brooklyn, New York 11219 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Akron Children's Hospital | Akron, Ohio 44308-1062 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Dell Children's Medical Center of Central Texas | Austin, Texas 78723 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Stanford Cancer Center | Stanford, California 94305-5824 |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
Lehigh Valley Hospital - Muhlenberg | Bethlehem, Pennsylvania 18017 |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |