Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase III Study of Radiotherapy, High-Dose Cisplatin, Vincristine, and Cyclophosphamide, and Autologous Stem Cell Rescue in Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 3 to 21 at diagnosis NCI SJCRH-SJMB03 NCT00085202

Trial Description

Purpose:

Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood- forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.

This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.

Eligibility:

Eligibility criteria include the following:

• 3-21 years old at diagnosis
• No more than 1 month since surgery to remove the CNS tumor
• No previous chemotherapy or radiation therapy
• 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:

Stem cells or bone marrow will be collected from patients. Patients will then undergo one of two regimens of radiation therapy to the head and spine 5 days a week for 6 weeks. Six weeks after completing radiation therapy, patients will receive an infusion of vincristine and a 6-hour infusion of cisplatin on day 1 followed by a 1-hour infusion of cyclophosphamide on days 2-3. Patients will undergo donor stem cell transplant on day 5. They will receive an injection of filgrastim beginning on day 6 and continuing until blood counts return to normal. Patients will receive an infusion of vincristine on day 11.

Treatment may be repeated every 4 weeks for three courses.

Some patients will periodically undergo neurological examinations. After finishing treatment, patients will be evaluated every 3 months until 2.5 years after diagnosis and every 6 months until 6 years after diagnosis.

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

St. Jude Children's Research Hospital

Amar Gajjar, MD, Principal investigator		Ph: 901-595-4599 Email: amar.gajjar@stjude.org

U.S.A.
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
Pennsylvania
	Philadelphia
	Children's Hospital of Philadelphia
		Michael Fisher, MD	Ph:  215-590-3025
Tennessee
	Memphis
	St. Jude Children's Research Hospital
		Clinical Trials Office - St. Jude Children's Research Hospital	Ph:  901-495-4644
Texas
	Houston
	Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
		Murali Chintagumpala, MD	Ph:  832-822-4266
Australia
New South Wales
	Randwick
	Sydney Children's Hospital
		Richard Cohn, FRACP	Ph:  61-2-9382-1730
			Email: r.cohn@unsw.edu.au
	Westmead
	Children's Hospital at Westmead
		Stewart Kellie, MD	Ph:  61-2-9845-2141
			Email: stewartk@chw.edu.au
Queensland
	Brisbane
	Royal Children's Hospital
		Tim Hassall, MBBS, FRACP	Ph:  61-7-3636-9115
			Email: tim_hassall@health.qld.gov.au
Victoria
	Parkville
	Royal Children's Hospital
		David Ashley, MBBS, FRACP, PhD	Ph:  61-39-345-5652
Canada
Ontario
	Toronto
	Hospital for Sick Children
		Eric Bouffet, MD, MRCP	Ph:  416-813-8024
			Email: eric.bouffet@sickkids.ca

Registry Information
Official Title		Treatment of Patients with Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Trial Start Date		2003-08-29
Trial Completion Date		2010-08-02 (estimated)
Registered in ClinicalTrials.gov		NCT00085202
Date Submitted to PDQ		2004-04-22
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA21765