ZD6474 Alone and in Combination With Retinoic Acid in Pediatric Neuroblastoma
The goal of this clinical research study is to find the highest safe dose of the drug ZactimaTM (ZD6474) in patients with neuroblastoma or medulloblastoma that has gotten worse, has come back, or has not responded to the treatment.
-To determine the pharmacokinetics, safety, dose-limiting toxicities, and maximum tolerated dose of ZD6474, alone in children with medulloblastoma, and alone in combination with retinoic acid, in patients with relapsed or refractory neuroblastoma.
-To assess progression-free survival (PFS) and objective tumor response rates in children with relapsed and refractory neuroblastoma and medulloblastoma treated with ZD6474 +/- retinoic acid in the context of a Phase I trial.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of ZD6474 (Zactima) Alone and in Combination With Retinoic Acid in Relapsed and Refractory Pediatric Neuroblastoma|
- Maximum tolerated dose (MTD) [ Time Frame: 28 day cycles, first 2 cycles used to determine dose-limiting toxicity ] [ Designated as safety issue: Yes ]MTD is highest dose level in which 6 participants have been treated with at most 2 experiencing dose limiting toxicity (DLT).
|Study Start Date:||September 2007|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: ZD6474 + Retinoic Acid
Part A = ZD6474 Alone, Starting dose 50 mg/m^2 by mouth daily for 28 days; Part B, C = ZD6474 + Retinoic Acid 80 mg/m^2 by mouth twice daily for 2 consecutive weeks out of every four weeks (28 days).
Part A = Starting dose 50 mg/m^2 by mouth daily for 28 days; Part B, C = Starting dose 50 mg/m^2 by mouth daily on days 2-28.
Other Names:Drug: Retinoic Acid
Part B, C = 80 mg/m^2 by mouth twice daily for 2 consecutive weeks out of every four weeks (28 days).
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|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Peter E. Zage, MD, PhD||M.D. Anderson Cancer Center|