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Therapeutic Areas: Oncology | Neurology
Disease Category: Gliomas
Location: United States, OH

Clinical Trial Details

Overview

Research Study Summary

HGG-1MF: A Study of Bevacizumab Therapy in Patients with Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas

Purpose

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

  • To find out whether the combination of bevacizumab (as well as temozolomide, if you have a high-grade glioma) and radiation therapy followed by 12 months of bevacizumab and irinotecan (and temozolomide, if you have high grade glioma) is safe and to find out about the side effects of the treatment
  • To find out whether the use of the new combination of drugs works better than other treatments for high grade and diffuse intrinsic pontine gliomas that we have used in the past
  • To learn about the effects of bevacizumab on your tumor and your blood
  • To study surgically removed tumor tissue and blood to better understand the biological qualities of high grade gliomas
  • To study blood to better understand the biological qualities of diffuse intrinsic brainstem gliomas
  • To study the effect of bevacizumab on blood flow in the tumor by using special MRI techniques
  • To see if the biological qualities of the tumor tissue or blood relate to the results of the treatment given in this research study
  • To measure the effects of the disease and the treatment used in this research study on your emotional and physical well-being

Who will be included in this study?
Patients who are 3 years to 30 years of age who have been diagnosed with a brain tumor called either a high grade glioma or a diffuse intrinsic pontine glioma (DIPG) may be eligible to participate in this study.

What is involved?
Before you can participate in this study, you will take part in a screening process that will include:

  • A medical history
  • A physical examination
  • Blood tests
  • Urine test
  • A pregnancy test for females of childbearing potential
  • Scans of the brain (MRI)
  • Scans of the spine (MRI), if your doctor finds it necessary

The following tests will be done because you are participating on this study.
They are not part of normal cancer care.

  • Other scans of the brain taken at the same time as the MRI
  • Right knee x-ray for patients who have not reached full adult height
  • Tissue samples (high-grade gliomas only)

The following studies are optional and are not part of regular cancer care. You may decide not to participate in these special studies, but still receive the treatment portion of this study.

  • Optional quality of life study
  • Optional additional blood tests
  • Optional functional outcomes
  • Optional additional brain scans

What are the benefits?
Taking part in this study may or may not make your health better. While doctors hope this treatment will be more useful against cancer compared to the standard treatment, there is no proof of this yet. The potential benefit from treatment in this study is that the surgery, radiation therapy, and chemotherapy drugs may cause the cancer to stop growing, shrink for a period of time, or lessen the symptoms associated with the tumor. Information from this study will help doctors learn more about how bevacizumab and the other chemotherapy drugs combined with radiation treatment and surgery affect brain tumors. That information could help future cancer patients.

Will I get all the facts about the study?
Patients/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 the patient/parent/guardian and will be sure that all questions are answered. Study procedures will not begin until a patient/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

3 to 30 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: 155676

Date Last Changed: July 24, 2013


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