Status:
COMPLETED
Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem Glioma
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
2-21 years
Phase:
PHASE1
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.
Detailed 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 kil...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00472017
Start Date
April 1 2007
End Date
October 1 2011
Last Update
October 15 2012
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105