A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy
I. To comprehensively define the safety profile of monoclonal antibody Ch14.18 when
administered with sargramostim, aldesleukin, and isotretinoin after autologous stem cell
transplantation (ASCT) in patients with high-risk neuroblastoma.
I. To further describe and refine the event-free survival and overall survival estimates in
patients treated with this regimen.
II. To further describe the baseline characteristics of patients treated with these regimen.
III. To further describe the safety and toxicity of this regimen, in terms of number of
courses delivered per patient, number of dose reductions or stoppage, and number of toxic
deaths, in these patients.
IV. To further describe the immune reconstitution following ASCT based on laboratory data
obtained just before, during, and after treatment with this regimen.
V. To obtain correlative laboratory data to evaluate and describe mechanisms related to
response, toxicity of immune activation, and allergic phenomena.
OUTLINE: This is a multicenter study.
Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1,
3, and 5; monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5
and on days 7-10 of courses 2 and 4; and oral isotretinoin twice daily on days 11-24 of
course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5.
Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2
and 4. Treatment repeats every 24-32 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients may undergo blood and bone marrow sample collection periodically for correlative
After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for 4 years, and then annually thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number and type of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Up to 5 years
Children's Oncology Group
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Loma Linda University Medical Center||Loma Linda, California 92354|
|New York Medical College||Valhalla, New York 10595|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Rady Children's Hospital - San Diego||San Diego, California 92123-4282|
|Children's Hospitals and Clinics of Minnesota - Minneapolis||Minneapolis, Minnesota 55404|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|Duke University Medical Center||Durham, North Carolina 27710|
|Indiana University Medical Center||Indianapolis, Indiana 46202|
|University of Texas Southwestern Medical Center||Dallas, Texas|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Seattle Children's Hospital||Seattle, Washington 98105|
|Columbia University Medical Center||New York, New York 10032|
|Cook Children's Medical Center||Fort Worth, Texas 76104|
|C S Mott Children's Hospital||Ann Arbor, Michigan 48109|
|Childrens Hospital of Orange County||Orange, California 92868-3874|
|Children's Healthcare of Atlanta - Egleston||Atlanta, Georgia 30322|
|The Childrens Mercy Hospital||Kansas City, Missouri 64108|
|Children's Hospital Colorado||Aurora, Colorado 80045|
|Lucile Packard Children's Hospital Stanford University||Palo Alto, California 94304|
|University of California San Francisco Medical Center-Parnassus||San Francisco, California 94143|
|Children's Hospital-Main Campus||New Orleans, Louisiana 70118|