NCT00472017

Brief Summary

This phase I trial is studying the side effects and best dose of vandetanib when given together with radiation therapy in treating young patients with newly diagnosed diffuse brain stem glioma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

4.5 years

First QC Date

May 8, 2007

Last Update Submit

October 11, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood brain stem glioma

Outcome Measures

Primary Outcomes (1)

  • To estimate the maximum tolerated dose (MTD) and to determine the dose-limiting toxicity (DLT) of vandetanib administered concurrently with radiation therapy (RT) in pediatric patients with newly diagnosed diffuse brainstem glioma.

    3 Years

Secondary Outcomes (6)

  • To determine the toxicities associated with the chronic use of vandetanib in pediatric patients

    3 Years

  • To characterize the pharmacokinetics of vandetanib in pediatric patients

    3 Years

  • To evaluate the influence of specific polymorphisms on the pharmacokinetics of vandetanib in children

    3 Years

  • To prospectively investigate the role of innovative imaging techniques (e.g., perfusion/diffusion, susceptibility-weighted imaging, arterial spin labeling) in assessing the response to therapy, particularly in tumor vascularization and perfusion

    3 Years

  • To prospectively estimate the cumulative incidence of intratumoral hemorrhage in patients with diffuse brainstem glioma treated with vandetanib concurrently with and after RT in the context of a Phase I study

    3 Years

  • +1 more secondary outcomes

Study Arms (1)

Pediatric Diffuse Brainstem Glioma Patients

EXPERIMENTAL

Patients with newly diagnosed diffuse brainstem gliomas receive vandetanib.

Drug: vandetanib

Interventions

vandetanibDRUG

Oral vandetanib administration will start on the same day as RT. Treatment with vandetanib will extend for the entire duration of RT, and then will be continued after completion of RT for a maximum duration of 2 years.

Also known as: ZD6474, Zactima
Pediatric Diffuse Brainstem Glioma Patients

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* Diagnosis of 1 of the following: * Diffuse brainstem glioma * High-grade glioma originating from brainstem * Age must be greater than or equal to 2 years and less than 21 years * Newly diagnosed disease * Lansky OR Karnofsky performance status 40-100% * ANC ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ (transfusion independent) * Hemoglobin ≥ 8 g/dL (transfusion allowed) * Bilirubin \< 1.5 times upper limit of normal (ULN) for age * ALT \< 5 times ULN * Albumin ≥ 2 g/dL * Creatinine \< 2 times ULN for age OR glomerular filtration rate \> 70 mL/min * QTc interval \< 450 msec by EKG * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Study Officials

  • Alberto Broniscer, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 10, 2007

Study Start

April 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

US(1)