IRB Number:

06-002684

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Older children with low grade gliomas that have come back after surgery or are causing problems are often treated with radiation therapy. Younger children are usually treated first with chemotherapy but, if the tumor comes back after chemotherapy, they then often also get radiation therapy.

Radiation therapy can cause severe side effects (a problem that happens when the treatment affects the healthy parts of a patient's body). New types of radiation therapy can treat a
smaller area of the body and doctors think that patients who get these kinds of radiation might have fewer side effects. The purpose of this study is to test the safety and effectiveness of this "smaller field radiation" in patients with low grade gliomas. This study will also try to find out if the results of a special test performed on the tumor tissue are related to the way the tumor responds to radiation.

Who is Eligible to Participate in the Study?

-Age 3 years to 21 years old
-Diagnosis of juvenile pilocytic astrocytoma (JPA), pleomorphic JPA, diffuse
astrocytoma (fibrillary, gemistocytic, giant cell, or pleomorphic xanthoastrocytoma), low-grade
oligoastrocytoma, low-grade oligodendroglioma, or low grade glioma not otherwise specified
-Patients under age 10 years must have received at least one course of chemotherapy prior to entry on this study
-Patients over age 10 years may have received prior chemotherapy prior to entry
-Patients may not have received prior irradiation

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

- Physical exam and blood tests.
- Hearing test.
- CT scan
- Possible MRI scan
- Radiation therapy 5 days per week for 6 weeks.
- Each radiation treatment will last for about 15 minutes (longer if patient receives anesthesia).
-Completion of questionnaires

How long will the Study run?

The radiation treatments will last for six weeks. After the treatments are over, patients will have regular office visits and MRI scans to see how well they are doing. These will happen every three months during the first two years, then every six months during the third and fourth years and once during the fifth year. Patients will have yearly hearing tests for the first five years, and then once every five years thereafter.

If patient's pituitary gland was affected by the study radiation, they will get yearly tests to review their body's hormone production. We would like to continue to find out about the patient's health for about 10 years after the study closes
to new patients. Keeping in touch with the patient and checking on how their health is every year for a while after the study closes helps us understand the long-term effects of the study.

Sponsor(s): Children's Oncology Group (COG)

Study Activation/Registration Date: 06/01/2006

IRB Review and Approval Date: 05/18/2006

Study Type: Treatment

Projected Accrual: Up to 105 patients may be enrolled to participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Paula J. Schomberg, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/23/2008