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

St. Jude Children's Research Hospital

Status and phase: Completed; Phase 1

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: vandetanib

Study type: Interventional

Funder types: Other

Identifiers

NCT00472017

SJBG07-SJ

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Pediatric Diffuse Brainstem Glioma Patients

Experimental group

Description:

Patients with newly diagnosed diffuse brainstem gliomas receive vandetanib.

Treatment:

Drug: vandetanib