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

Alternate Title

Phase III Pilot Study of Induction Chemotherapy Followed by Consolidation Myeloablative Chemotherapy Comprising Thiotepa and Carboplatin With or Without Etoposide and Autologous Hematopoietic Stem Cell Rescue in Pediatric Patients With Previously Untreated Malignant Brain Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active Under 10 at diagnosis Other CHLA-HEAD-START-III CHLA-HSIII, CHLA-2004-020, CHLA-04.020, NCT00392886, UMN-MT2004-06

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. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood -forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.

This phase III trial is studying how well giving combination chemotherapy with or without etoposide followed by an autologous stem cell transplant works in treating young patients with previously untreated malignant brain tumors.

Eligibility:

Eligibility criteria include the following:

• Younger than 10 years old at diagnosis
• No previous treatment for this cancer
• Has undergone surgery within the past 6 weeks
• No previous radiation therapy or chemotherapy
• 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 will undergo bone marrow or peripheral blood stem cell collection before beginning chemotherapy and after the first course of chemotherapy.

Some patients will receive an infusion of vincristine on days 1, 8, and 15 during courses one, two, and three, temozolomide by mouth once a day on days 1-5, and a 4-hour infusion of carboplatin on days 1 and 2. Beginning on day 6, they will receive an injection of G-CSF once a day until blood counts return to normal. Treatment may repeat every 4 weeks for up to four courses. Patients will then receive a 4-hour infusion of carboplatin on days 1-3 and a 3-hour infusion of thiotepa on days 4-6. They will receive an infusion of their bone marrow or peripheral blood stem cells on day 9. Beginning on day 10, patients will receive an injection of G-CSF once a day until blood counts return to normal. Beginning within 6 weeks after stem cell transplant, some patients may undergo radiation therapy 5 days a week for up to 6 weeks.

During courses one, three, and five, other patients will receive a 6-hour infusion of cisplatin on day 1, a 1-hour infusion of cyclophosphamide and a 2-hour infusion of etoposide on days 2 and 3, a 4-hour infusion of methotrexate on day 4, and an injection of G-CSF beginning on day 5 and continuing until blood counts return to normal. They will also receive an infusion of vincristine on days 1, 8, and 15 during courses one and three. During courses two and four, patients will receive temozolomide by mouth once a day on days 1-5, etoposide by mouth once a day on days 1-10, a 1-hour infusion of cyclophosphamide on days 11 and 12, and an injection of G-CSF beginning on day 13 and continuing until blood counts return to normal. They will also receive an infusion of vincristine on days 1, 8, and 15 during course two. Treatment may repeat every 4 weeks for five courses. After finishing course five, patients will receive a 4-hour infusion of carboplatin on days 1-3 and 3-hour infusions of thiotepa and etoposide on days 4-6. They will receive an infusion of their bone marrow or peripheral blood stem cells on day 9. Beginning on day 10, patients will receive an injection of G-CSF once a day until blood counts return to normal. Beginning within 6 weeks after stem cell transplant, some patients may undergo radiation therapy 5 days a week for up to 6 weeks.

All patients will undergo assessment of brain and nervous system function, hormone levels, and quality of life periodically.

After finishing treatment, patients will be evaluated periodically.

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

Childrens Hospital Los Angeles

Jonathan Finlay, MB, ChB, Protocol chair		Ph: 323-361-8147 Email: jfinlay@chla.usc.edu
Girish Dhall, MD, Protocol co-chair		Ph: 323-361-8589 Email: gdhall@chla.usc.edu
Kelley Haley, RN, BSN, Research coordinator		Ph: 323-361-2480 Email: khaley@chla.usc.edu

U.S.A.
Arizona
	Phoenix
	Phoenix Children's Hospital Outpatient Center
		Michael Etzl, MD	Ph:  602-546-0920
			Email: metzl@phoenixchildrens.com
California
	Loma Linda
	Loma Linda University Cancer Institute at Loma Linda University Medical Center
		Clinical Trials Office - Loma Linda University Cancer Institute	Ph:  909-558-3375
	Long Beach
	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
		Ramesh Patel, MD	Ph:  562-933-8600
	Los Angeles
	Childrens Hospital Los Angeles
		Jonathan Finlay, MB, ChB	Ph:  323-361-8147
			Email: jfinlay@chla.usc.edu
	Mattel Children's Hospital at UCLA
		Joseph Lasky, MD	Ph:  310-825-6708
			Email: jlasky@mednet.ucla.edu
	Oakland
	Children's Hospital and Research Center Oakland
		Clinical Trial Office - Children's Hospital and Research Center Oakland	Ph:  510-450-7600
	Orange
	Children's Hospital of Orange County
		Wei-Ping Shen, MD	Ph:  714-516-4348
			Email: vshen@choc.org
Delaware
	Wilmington
	Alfred I. duPont Hospital for Children
		Clinical Trials Office - Alfred I. duPont Hospital for Children	Ph:  302-651-5755
Florida
	Jacksonville
	Nemours Children's Clinic
		Michael Joyce, MD, PhD	Ph:  904-390-3793
			Email: mjoyce@nemours.org
Illinois
	Chicago
	Children's Memorial Hospital - Chicago
		Stewart Goldman, MD	Ph:  773-880-4585
	University of Chicago Comer Children's Hospital
		Charles Rubin, MD	Ph:  773-702-6808 800-289-6333
			Email: crubin@uchicago.edu
Indiana
	Indianapolis
	Riley's Children Cancer Center at Riley Hospital for Children
		Kamnesh Pradhan, MD	Ph:  317-274-8784
			Email: pkamnesh@iupui.edu
Kentucky
	Louisville
	Kosair Children's Hospital
		Clinical Trials Office - Kosair Children's Hospital	Ph:  502-629-5500
			Email: CancerResource@nortonhealthcare.org
Michigan
	Grand Rapids
	Helen DeVos Children's Hospital at Spectrum Health
		Clinical Trials Office - Helen DeVos Children's Hospital	Ph:  616-391-3050
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
Missouri
	Kansas City
	Children's Mercy Hospital
		Richard Shore, MD	Ph:  816-234-3265
			Email: rwshore@cmh.edu
New Jersey
	Hackensack
	Tomorrows Children's Institute at Hackensack University Medical Center
		Steven Halpern, MD	Ph:  201-996-5437
			Email: bdhalpern@aol.com
New York
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine	Ph:  718-904-2730
			Email: aecc@aecom.yu.edu
	New Hyde Park
	Schneider Children's Hospital
		Mark Atlas, MD	Ph:  718-470-3460
			Email: matlas@lij.edu
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	NYU Cancer Institute at New York University Medical Center
		Sharon Gardner, MD	Ph:  212-263-8520
			Email: sharon.gardner@med.nyu.edu
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Rainbow Babies and Children's Hospital
		Susan Wiersma, MD	Ph:  216-844-3345
	Columbus
	Nationwide Children's Hospital
		Amanda Termuhlen, MD	Ph:  614-722-3552
	Toledo
	St. Vincent Mercy Medical Center
		Rama Jasty, MD	Ph:  419-251-8215
			Email: rjasty@med.umich.edu
	Toledo Children's Hospital
		Dagmar Stein, MD, PhD	Ph:  419-291-7815
			Email: dagmar.stein@promedica.org
Pennsylvania
	Hershey
	Penn State Children's Hospital
		Melanie Comito, MD	Ph:  717-531-6012 800-243-1455
			Email: mac36@psu.edu
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
Australia
Western Australia
	Perth
	Princess Margaret Hospital for Children
		David Baker, MD, MBBS, FRACP, FRCPA	Ph:  61-8-9340-8234
Canada
British Columbia
	Vancouver
	Children's & Women's Hospital of British Columbia
		Paul Rogers, MB, ChB, FRCPC, MBA, FRCP	Ph:  604-875-2322
			Email: progers@cw.bc.ca
Manitoba
	Winnipeg
	CancerCare Manitoba
		David Eisenstat, MD	Ph:  204-787-1169
			Email: eisensta@cc.umanitoba.ca
Ontario
	Toronto
	Hospital for Sick Children
		Annie Huang, MD	Ph:  416-813-7360
New Zealand
	Christchurch
	Christchurch Hospital
		Michael Sullivan, MD, PhD, FRACP	Ph:  64-3-364-0744
			Email: micke.sullivan@otago..ac.nz
	Wellington
	Wellington Children's Hospital
		Elizabeth Hesketh, MD	Ph:  64-4-918-5091
			Email: liz.hesketh@ccdhb.org.nz
Switzerland
	Bern
	Swiss Pediatric Oncology Group Bern
		Andreas Hirt, MD	Ph:  41-31-632-9495
			Email: andreas.hirt@insel.ch
	Universitaets Kinderklinik
		Andreas Hirt, MD	Ph:  41-31-632-9495

Registry Information
Official Title		Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed with Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation with Myeloablative Chemotherapy (Thiotepa and Carboplatin, With or Without Etoposide) and Autologous Stem Cell Rescue [HEAD START III]
Trial Start Date		2004-03-22
Trial Completion Date		2010-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00392886
Date Submitted to PDQ		2006-10-17
Information Last Verified		2008-10-20