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Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem Glioma

NCT ID: NCT00472017

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving vandetanib together with radiation therapy may kill more tumor cells.

Patients undergo conformal radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive oral vandetanib once daily beginning on the same day as radiotherapy and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of vandetanib until the maximum tolerated dose (MTD) is determined.

Blood samples are collected periodically for pharmacokinetic studies, polymorphism analysis (e.g., CYP3A4/5), and immunological laboratory methods (e.g., western blot assay). Imaging studies are also conducted periodically.

Conditions

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Brain and Central Nervous System Tumors

Keywords

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untreated childhood brain stem glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pediatric Diffuse Brainstem Glioma Patients

Patients with newly diagnosed diffuse brainstem gliomas receive vandetanib.

Group Type EXPERIMENTAL

vandetanib

Intervention Type DRUG

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.

Interventions

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vandetanib

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.

Intervention Type DRUG

Other Intervention Names

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ZD6474 Zactima

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alberto Broniscer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

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SJBG07-SJ

Identifier Type: -

Identifier Source: org_study_id