Phase I/II Study of MLN8237 in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity
To estimate the maximum tolerated dose (MTD), toxicities and pharmacokinetics of MLN8237 when given together with fixed doses of irinotecan and temozolomide in children and young adults with relapsed or refractory neuroblastoma. To determine the response rate for patients with relapsed or refractory neuroblastoma treated with MLN8237, irinotecan, and temozolomide at the identified MTD
21 days, from study day 1
Yes
Steven DuBois, MD
Study Chair
University of California, San Francisco
United States: Food and Drug Administration
N2009-03
NCT01601535
May 2012
May 2016
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto, California 95798 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
University of Chicago Comer Children's Hospital | Chicago, Illinois 60637 |
Childrens Hospital Boston, Dana-Farber Cancer Institute. | Boston, Massachusetts 02115 |
Duke University Medical Center | Durham, North Carolina 27710 |
Children's Healthcare of Atlanta | Atlanta, Georgia 30342 |