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

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00472017
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
54
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Trial of Vandetanib (ZD6474, ZACTIMA) With Concurrent Radiation in Treatment of Newly Diagnosed Brainstem Glioma
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pediatric Diffuse Brainstem Glioma Patients

Patients with newly diagnosed diffuse brainstem gliomas receive vandetanib.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [3 Years]

    Secondary Outcome Measures

    1. To determine the toxicities associated with the chronic use of vandetanib in pediatric patients [3 Years]

    2. To characterize the pharmacokinetics of vandetanib in pediatric patients [3 Years]

    3. To evaluate the influence of specific polymorphisms on the pharmacokinetics of vandetanib in children [3 Years]

    4. 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 [3 Years]

    5. 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 [3 Years]

    6. 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 [3 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital

    Investigators

    • Principal Investigator: Alberto Broniscer, MD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT00472017
    Other Study ID Numbers:
    • SJBG07-SJ
    First Posted:
    May 10, 2007
    Last Update Posted:
    Oct 15, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by St. Jude Children's Research Hospital
    untreated childhood brain stem glioma
    Additional relevant MeSH terms:
    Glioma
    Nervous System Neoplasms
    Central Nervous System Neoplasms

    Study Results

    No Results Posted as of Oct 15, 2012