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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00472017
First received: May 8, 2007
Last updated: October 11, 2012
Last verified: October 2012

May 8, 2007
October 11, 2012
April 2007
October 2011   (final data collection date for primary 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. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • Dose-limiting toxicity
  • Maximum tolerated dose
Complete list of historical versions of study NCT00472017 on ClinicalTrials.gov Archive Site
  • To determine the toxicities associated with the chronic use of vandetanib in pediatric patients [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • To characterize the pharmacokinetics of vandetanib in pediatric patients [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • To evaluate the influence of specific polymorphisms on the pharmacokinetics of vandetanib in children [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • Prospectively assess the number of circulating endothelial cells and circulating endothelial progenitors before the start and during therapy and, if possible, to correlate these findings with tumor response, imaging studies, and other biological assays [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • Toxicity
  • Pharmacokinetics
  • Influence of polymorphisms on pharmacokinetics
  • Role of innovative imaging techniques
  • Cumulative incidence of intratumoral hemorrhage
  • Correlation of number of circulating endothelial cells and circulating endothelial progenitors with tumor response, imaging studies, and other biological assays
Not Provided
Not Provided
 
Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem Glioma
Phase I Trial of Vandetanib (ZD6474, ZACTIMA) With Concurrent Radiation in Treatment of Newly Diagnosed Brainstem Glioma

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Drug: 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.
Other Names:
  • ZD6474
  • Zactima
Experimental: Pediatric Diffuse Brainstem Glioma Patients
Patients with newly diagnosed diffuse brainstem gliomas receive vandetanib.
Intervention: Drug: vandetanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
October 2011
October 2011   (final data collection date for primary outcome measure)
  • 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
Both
2 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00472017
SJBG07-SJ
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Alberto Broniscer, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP