drugset / Trial / NCT00533169
ZD6474 Alone and in Combination With Retinoic Acid in Pediatric Neuroblastoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isotretinoin | Other / unclassified | 80 mg/m2 | Oral |
| Subject | Vandetanib | Small molecule | 50 mg/m2 | Oral |