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

Clinical Trial Details

Overview

Research Study Summary

ADVL0815: A Phase I Study of Pazopanib as a Single Agent for Children with Refractory Solid Tumors

Purpose

What is the purpose of this study?

  • To find the highest safe dose of pazopanib that can be given without causing severe side effects
  • To learn what kind of side effects pazopanib can cause
  • To learn more about the pharmacology (how the body handles the drug) of pazopanib
  • To learn about the effects of pazopanib on cells and proteins in the blood
  • To assess the effect of pazopanib on blood flow in the tumor by using MRI
  • To determine whether pazopanib is a beneficial treatment for the tumor

Who will be included in this study?
Patients between the ages 1 and 21 years who have a recurrent or progressive tumor that cannot be cured by any known standard treatment may be eligible to take part in this study.

What is involved?
Before beginning the study patients will need to have the following exams, tests or procedures to find out if they are eligible to participate in the study:

  • A medical history
  • Physical exam
  • Blood tests
  • Urine tests
  • Pregnancy test (for females of childbearing age)
  • Echocardiogram (which tests the function of the heart)
  • X-rays, CT scan, or other tests to check the tumor

During the study the following tests will also be given to make sure that the patient is not having unsafe side effects and to see whether or not the tumor is responding to pazopanib:

  • Medical history
  • Physical exam with vital signs
  • Blood pressure
  • Blood tests
  • Urine tests
  • Pregnancy test (for females of childbearing age)
  • Echocardiogram (which tests the function of the heart)
  • CT/ MRI of the tumor

What are the benefits?
There may be no direct benefit to participation in this research study. The potential benefit of the treatment with pazopanib is that it may cause the cancer to stop growing or to shrink for a period of time. It may lessen the symptoms, such as pain, that are caused by the cancer. Because there is not much information about the pazopanib effect on cancers in humans, we do not know if there will be direct benefit from taking part in this study. Information learned from this study may help future patients with cancer.

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 the parent/patient and will be sure that all 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
Phase

1

Gender

Both Male and Female

Age

1 to 21 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Division of Hematology/Oncology
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: 158247

Date Last Changed: July 24, 2013


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