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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00472017
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE May 8, 2007
First Posted Date  ICMJE May 10, 2007
Last Update Posted Date October 15, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
  • Maximum tolerated dose
  • Dose-limiting toxicity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • To determine the toxicities associated with the chronic use of vandetanib in pediatric patients [ Time Frame: 3 Years ]
  • To characterize the pharmacokinetics of vandetanib in pediatric patients [ Time Frame: 3 Years ]
  • To evaluate the influence of specific polymorphisms on the pharmacokinetics of vandetanib in children [ Time Frame: 3 Years ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem Glioma
Official Title  ICMJE Phase I Trial of Vandetanib (ZD6474, ZACTIMA) With Concurrent Radiation in Treatment of Newly Diagnosed Brainstem Glioma
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Pediatric Diffuse Brainstem Glioma Patients
Patients with newly diagnosed diffuse brainstem gliomas receive vandetanib.
Intervention: Drug: vandetanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
35
Original Enrollment  ICMJE
 (submitted: May 8, 2007)
28
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00472017
Other Study ID Numbers  ICMJE SJBG07-SJ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alberto Broniscer, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date October 2012

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