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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 Induction Chemotherapy With or Without Filgrastim (G-CSF) Followed By Surgery, Myeloablative Therapy, and Radiotherapy With Isotretinoin With or Without Monoclonal Antibody Ch14.18 in Patients With High-Risk Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	1 to 20 at diagnosis	Other	SIOP-EUROPE-HR-NBL-1 ESIOP, EU-20148, NCT00030719

Trial Description

Purpose:

Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma.

This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma.

Eligibility:

Eligibility criteria include the following:

• 1-20 years old at diagnosis
• 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 be randomly assigned to one of eight groups.

Patients will receive infusions of combination chemotherapy with or without injections of filgrastim followed by stem cell collection. Approximately 2 weeks after stem cell collection, they will undergo surgery to remove the tumor. Patients will then receive one of two different high-dose chemotherapy regimens followed by reinfusion of stem cells and a 3-week course of radiation therapy. Within one month after radiation therapy, patients will receive isotretinoin by mouth twice a day for 2 weeks with or without an infusion of monoclonal antibody.

Treatment in all groups will occur over approximately 6 months. All patients will be evaluated every 6 months for 3 years and once a year for 2 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

University Hospitals of Leicester NHS Trust

Ruth Ladenstein, MD, Protocol chair		Ph: 43-1-404-700

Austria
	Vienna
	St. Anna Children's Hospital
		Ruth Ladenstein, MD	Ph:  43-1-404-700
Belgium
	Ghent
	Universitair Ziekenhuis Gent
		Genevieve Laureys, MD, PhD	Ph:  32-9-240-21-11
			Email: Genevieve.Laureys@UGent.be
Denmark
	Aarhus
	Aarhus Universitetshospital - Aarhus Sygehus
		Henrik Schroder, MD	Ph:  45-89-49-44-44
France
	Villejuif
	Institut Gustave Roussy
		D. Valteau-Couanet	Ph:  33-1-4211-4339
Ireland
	Dublin
	Our Lady's Hospital for Sick Children Crumlin
		Fin Breatnach, MD, FRCPE	Ph:  353-1-409-6659
			Email: fin.breatnach@olhsc.ie
Israel
	Petah-Tikva
	Schneider Children's Medical Center of Israel
		Isaac Yaniv, MD	Ph:  972-3-925-3669
			Email: iyaniv@clalit.org.il
Italy
	Milan
	Fondazione Istituto Nazionale dei Tumori
		Roberto Luksch, MD	Ph:  39-02-2390-2592
			Email: luksch@institutotumori.mi.it
Norway
	Oslo
	Rikshospitalet University Hospital
		Ingebjorg Storm-Mathisen, MD	Ph:  47-23-07-45-60
Portugal
	Lisbon
	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
		Ana Forjaz De Lacerda, MD, FAAP	Ph:  351-21-726-0429
			Email: hdiap@ipolisboa.min-saude.pt
Spain
	Valencia
	Hospital Universitario La Fe
		Victoria Castel	Ph:  34-96-386-2700
Sweden
	Stockholm
	Karolinska University Hospital - Solna
		Per Kogner, MD, PhD	Ph:  46-85-177-3534
			Email: per.kogner@ki.se
Switzerland
	Lausanne
	Centre Hospitalier Universitaire Vaudois
		Maja Popovic, MD	Ph:  41-21-314-3567
			Email: maja.beck-popovic@chuv.ch
United Kingdom
England
	Birmingham
	Birmingham Children's Hospital
		Martin English, MD	Ph:  44-121-333-8412
			Email: martin.english@bch.nhs.uk
	Bristol
	Institute of Child Health at University of Bristol
		Pamela Kearns, MD	Ph:  44-117-342-8260
	Cambridge
	Addenbrooke's Hospital
		Amos Burke, MD	Ph:  44-1223-348-151
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Adam Glaser, MD	Ph:  44-113-206-4984
			Email: adam.glaser@leedsth.nhs.uk
	Leicester
	Leicester Royal Infirmary
		Johann Visser, MD	Ph:  44-116-258-5309
			Email: johannes.visser@uhl-tr.nhs.uk
	Liverpool
	Royal Liverpool Children's Hospital, Alder Hey
		Heather McDowell, MD	Ph:  44-151-293-3679
	London
	Great Ormond Street Hospital for Children
		Penelope Brock, MD, PhD	Ph:  44-20-7829-7924
			Email: Brockp@gosh.nhs.uk
	Middlesex Hospital
		Ananth Shankar, MD	Ph:  44-20-7380-9300 ext. 9950
	Manchester
	Royal Manchester Children's Hospital
		Bernadette Brennan, MD	Ph:  44-161-922-2227
			Email: bernadette.brennan@cmmc.nhs.uk
	Newcastle-Upon-Tyne
	Sir James Spence Institute of Child Health at Royal Victoria Infirmary
		Juliet Hale, MD	Ph:  44-191-282-4101
			Email: j.p.hale@ncl.ac.uk
	Nottingham
	Queen's Medical Centre
		Martin Hewitt, MD, BSc, FRCP, FRCPCH	Ph:  44-115-924-9924 ext. 43394
			Email: martin.hewitt@nuh.nhs.uk
	Oxford
	Oxford Radcliffe Hospital
		Kate Wheeler, MD	Ph:  44-186-522-1066
	Sheffield
	Children's Hospital - Sheffield
		Mary Gerrard, MBChB, FRCP, FRCPCH	Ph:  44-114-271-7366
			Email: mary.gerrard@sch.nhs.uk
	Southampton
	Southampton General Hospital
		Janice Kohler, MD, FRCP	Ph:  44-23-8079-6942
	Sutton
	Royal Marsden - Surrey
		Mary Taj, MD	Ph:  44-20-8642-6011 ext. 1307
Northern Ireland
	Belfast
	Royal Belfast Hospital for Sick Children
		Anthony McCarthy, MD	Ph:  44-289-063-3631
			Email: anthonymcarthy@royalhospital.n.i.nhs.uk
Scotland
	Aberdeen
	Royal Aberdeen Children's Hospital
		Veronica Neefjes	Ph:  44-1224-550-217
	Edinburgh
	Royal Hospital for Sick Children
		W. Hamish Wallace, MD	Ph:  44-131-536-0426
	Glasgow
	Royal Hospital for Sick Children
		Milind Ronghe, MD	Ph:  44-141-201-9309
Wales
	Cardiff
	Childrens Hospital for Wales
		Heidi Traunecker, MD, PhD	Ph:  44-29-2074-2285
			Email: heidi.traunecker@cardiffandvale.wales.nhs.uk

Registry Information
Official Title		High Risk Neuroblastoma Study 1 Of Siop-Europe
Trial Start Date		2001-12-15
Registered in ClinicalTrials.gov		NCT00030719
Date Submitted to PDQ		2001-12-14
Information Last Verified		2008-01-02

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