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Phase I Trial of Vandetanib (ZD6474, ZACTIMA) With Concurrent Radiation in Treatment of Newly Diagnosed Brainstem Glioma


Phase 1
2 Years
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase I Trial of Vandetanib (ZD6474, ZACTIMA) With Concurrent Radiation in Treatment of Newly Diagnosed Brainstem Glioma


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 Years

Safety Issue:

Yes

Principal Investigator

Alberto Broniscer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

SJBG07-SJ

NCT ID:

NCT00472017

Start Date:

April 2007

Completion Date:

October 2011

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood brain stem glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794