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ZD6474 Alone and in Combination With Retinoic Acid in Pediatric Neuroblastoma

NCT00533169 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-12-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ZD6474

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.

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).

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Peter E. Zage, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00533169 on ClinicalTrials.gov