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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Standard Chemoradiotherapy With Versus Without High-Dose Methotrexate in Pediatric Patients With Newly Diagnosed, Malignant High-Grade Glioma or Diffuse Intrinsic Pontine Glioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 3 to 18 Other GPOH-HIT-GBM-D EU-205100, NCT00278278

Trial Description

Purpose:

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving methotrexate together with combination chemotherapy and radiation therapy is more effective than combination chemotherapy and radiation therapy alone in treating gliomas.

This randomized phase III trial is studying giving methotrexate together with combination chemotherapy and radiation therapy to see how well it works compared to combination chemotherapy and radiation therapy alone in treating young patients with newly diagnosed gliomas.

Eligibility:

Eligibility criteria include the following:

• 3-18 years old
• No previous chemotherapy or radiation therapy for brain tumors
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients may undergo surgery to remove the tumor. Within the next 2 weeks they will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive a 1-day infusion of methotrexate in weeks 1 and 3. They will also recieve an infusion of leucovorin four times a day for 2 days in weeks 1 and 3. Four weeks later they will undergo radiation therapy once a day 5 days a week for approximately 6 weeks. At the same time, patients will receive combination chemotherapy by infusion.

Patients in group two will undergo radiation therapy once a day 5 days a week for approximately 6 weeks. At the same time, they will receive combination chemotherapy by infusion.

Beginning 4 weeks later, patients in both groups will receive an infusion of vincristine once a week for 3 weeks, lomustine by mouth once in week 1, and prednisone by mouth once a day for approximately 2½ weeks. Treatment may repeat every 6 weeks for up to eight courses.

Quality of life will be assessed 1 week after surgery, once during treatment, at 1, 4, and 13 months after finishing treatment, and then once a year for 3 years.

After finishing treatment, patients will be evaluated periodically for 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Gesellschaft fuer Paediatrische Onkologie und Haematologie - Germany

Christoph Kramm, MD, Protocol chair		Ph: 49-345-557-2388 Email: christoph.kramm@medizin.uni-halle.de

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245

Registry Information
Official Title		Treatment of Children and Adolescents with Diffuse Intrinsic Pontine Glioma and High Grade Glioma
Trial Start Date		2003-09-01
Registered in ClinicalTrials.gov		NCT00278278
Date Submitted to PDQ		2005-09-15
Information Last Verified		2008-11-21