A Comparative Pharmacokinetic and Safety Study of Chimeric Monoclonal Antibody ch14.18 With Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interleukin-2 (IL-2) and Isotretinoin in High Risk Neuroblastoma Patients Following Myeloablative Therapy
This is a multi-center, randomized, open-label, two-sequence, cross-over study for eligible
subjects with high-risk neuroblastoma to assess the comparability of ch14.18 manufactured
with UTC drug product and ch14.18 manufactured with NCI drug product. Subjects will be
randomly allocated to receive ch14.18 manufactured by UTC or NCI during Courses 1 and 2
followed by ch14.18 manufactured by other manufacturer (UTC or NCI) during Courses 3, 4, and
5.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Area under the plasma concentration curve (AUC)
Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin
6 months
No
Araz Marachelian, MD
Study Chair
Children's Hospital Los Angeles
United States: Food and Drug Administration
DIV-NB-201
NCT01592045
August 2012
July 2013
Name | Location |
---|---|
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
Duke University Medical Center | Durham, North Carolina 27710 |
The University of Chicago | Chicago, Illinois 60637 |
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 |
Children's Hospital of Los Angeles | Los Angeles, California 90027 |
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia 30322 |
Children's Mercy Hospital (Kansas) | Kansas, Missouri 64108 |
University of Michigan C.S. Mott Children's Hospital | Ann Arbor, Michigan 48109 |