drugset / Trial / NCT00533169

ZD6474 Alone and in Combination With Retinoic Acid in Pediatric Neuroblastoma

NCT00533169

Phase 1 Terminated 10 enrolled M.D. Anderson Cancer Center AstraZeneca · collab
NaSingle-groupOpen-labelTreatment

Summary

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. Primary Objective: -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. Secondary Objective: -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.

Timeline

Start
2007-09
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Isotretinoin Other / unclassified 80 mg/m2 Oral
Subject Vandetanib Small molecule 50 mg/m2 Oral

Indications