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Therapeutic Areas: Oncology | Family Medicine
Disease Category: Solid Tumors
Location: United States, OH

Clinical Trial Details

Overview

Research Study Summary

VITAC: A Pilot Study of the Addition of Bevacizumab to Vincristine, Oral Irinotecan and Temozolomide (VOIT regiment) for Relapsed/Refractory Pediatric Solid Tumors

Purpose

What is the purpose of this study?
The goals of this research study are:

  • To test the safety of adding bevacizumab to the established regimen of vincristine, oral irinotecan, and temozolomide (VOIT)
  • To see what effects (good and bad) it has on children and children’s cancer

Who will be included in this study?
Patients with any solid tumor who are > 12 months or = 21 years old are eligible to participate in this clinical trial.

What is involved?
Patients receive bevacizumab and the VOIT regimen every three weeks. Patients who do not have serious side effects and whose tumor is not getting worse may continue to receive up to 6 courses of treatment.

Before patients can participate in this study, they will take part in a screening process that will include:

  • Physical exam
  • Blood tests to check counts of blood cells and to evaluate kidney and liver function
  • Urine tests
  • Pregnancy test for females of childbearing age
  • Scans to evaluate the tumor (the doctor will determine the best type of scan, e.g. CT scan or MRI)

The following tests are all necessary to make sure that patients are not having unsafe side effects of bevacizumab:

  • Physical exam
  • Blood tests
  • Urine tests
  • Scans to evaluate the tumor (the doctor will determine the best type of scan, e.g. CT scan or MRI)

What are the benefits?
Your child may receive no direct benefit from participating in this study. The biggest benefit is that your child may be helping other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools.

Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects can be provided to those patients interested in knowing more about the study.

To Learn more
Gender

Both Male and Female

Age

12 to 21 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Phone: 513-636-2799

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 155677

Date Last Changed: July 24, 2013


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