Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma - Full Text View

Sponsor:	University Hospitals, Leicester
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030719

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Neuroblastoma	Biological: filgrastim Biological: monoclonal antibody Ch14.18 Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: isotretinoin Drug: melphalan Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	High Risk Neuroblastoma Study 1 Of Siop-Europe

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival at 3 years [ Designated as safety issue: No ]
Mean number of febrile events during induction [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate assessed by the International Neuroblastoma Response Criteria after 4 and 8 induction chemotherapy courses [ Designated as safety issue: No ]
Event-free survival at 5 years [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Biological factors (i.e., MycNM amplification, 1p deletion, ploidy, 17 q+, CD44, and Trk-A) [ Designated as safety issue: No ]
Serum concentrations of lactic dehydrogenase, ferritin, neurone specific enolase [ Designated as safety issue: No ]
Urinary catecholamines at diagnosis [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	December 2001

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of neuroblastoma according to International Neuroblastoma Staging System
- Stage 2 or 3 with MycN amplification
- Stage 4
Tumor material available for determination of biological prognostic factors

PATIENT CHARACTERISTICS:

Age:

1 to 20 at diagnosis

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin less than 3 times normal
ALT less than 3 times normal

Renal:

Creatinine less than 1.5 mg/mL
Creatinine clearance and/or glomerular filtration rate at least 60 mL/min

Cardiovascular:

Shortening fraction at least 28% OR
Ejection fraction at least 55%
No clinical congestive heart failure

Pulmonary:

Chest x-ray normal
Oxygen saturation normal

Other:

HIV negative
No Brock grade 2 or greater
No uncontrolled infections requiring IV antivirals, antibiotics, or antifungals
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No more than 1 prior chemotherapy regimen for localized unresectable disease
No concurrent anthracyclines
No other concurrent chemotherapy

Endocrine:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No other concurrent investigational therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030719

Hide Study Locations

Locations

Austria
St. Anna Children's Hospital	Recruiting
Vienna, Austria, A-1090
Contact: Ruth Ladenstein, MD 43-1-404-700
Belgium
Universitair Ziekenhuis Gent	Recruiting
Ghent, Belgium, B-9000
Contact: Genevieve Laureys, MD, PhD 32-9-240-21-11 Genevieve.Laureys@UGent.be
Denmark
Aarhus Universitetshospital - Aarhus Sygehus	Recruiting
Aarhus, Denmark, DK-8000
Contact: Henrik Schroder, MD 45-89-49-44-44
France
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: D. Valteau-Couanet 33-1-4211-4339
Ireland
Our Lady's Hospital for Sick Children Crumlin	Recruiting
Dublin, Ireland, 12
Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie
Israel
Schneider Children's Medical Center of Israel	Recruiting
Petah-Tikva, Israel, 49202
Contact: Isaac Yaniv, MD 972-3-925-3669 iyaniv@clalit.org.il
Italy
Fondazione Istituto Nazionale dei Tumori	Recruiting
Milan, Italy, 20133
Contact: Roberto Luksch, MD 39-02-2390-2592 luksch@institutotumori.mi.it
Norway
Rikshospitalet University Hospital	Recruiting
Oslo, Norway, 0027
Contact: Ingebjorg Storm-Mathisen, MD 47-23-07-45-60
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA	Recruiting
Lisbon, Portugal, 1099-023 Codex
Contact: Ana Forjaz De Lacerda, MD, FAAP 351-21-726-0429 hdiap@ipolisboa.min-saude.pt
Spain
Hospital Universitario La Fe	Recruiting
Valencia, Spain, 46009
Contact: Victoria Castel 34-96-386-2700
Sweden
Karolinska University Hospital - Solna	Recruiting
Stockholm, Sweden, S-171 76
Contact: Per Kogner, MD, PhD 46-85-177-3534 per.kogner@ki.se
Switzerland
Centre Hospitalier Universitaire Vaudois	Recruiting
Lausanne, Switzerland, CH-1011
Contact: Maja B. Popovic, MD 41-21-314-3567 maja.beck-popovic@chuv.ch
United Kingdom, England
Great Ormond Street Hospital for Children	Recruiting
London, England, United Kingdom, WC1N 3JH
Contact: Penelope Brock, MD, PhD 44-20-7829-7924 Brockp@gosh.nhs.uk
Birmingham Children's Hospital	Recruiting
Birmingham, England, United Kingdom, B4 6NH
Contact: Martin W. English, MD 44-121-333-8412 martin.english@bch.nhs.uk
Children's Hospital - Sheffield	Recruiting
Sheffield, England, United Kingdom, S10 2TH
Contact: Mary P. Gerrard, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk
Addenbrooke's Hospital	Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Amos Burke, MD 44-1223-348-151
Institute of Child Health at University of Bristol	Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: Pamela Kearns, MD 44-117-342-8260
Leeds Cancer Centre at St. James's University Hospital	Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk
Leicester Royal Infirmary	Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Johann Visser, MD 44-116-258-5309 johannes.visser@uhl-tr.nhs.uk
Middlesex Hospital	Recruiting
London, England, United Kingdom, W1T 3AA
Contact: Ananth Shankar, MD 44-20-7380-9300 ext. 9950
Royal Manchester Children's Hospital	Recruiting
Manchester, England, United Kingdom, M27 4HA
Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk
Queen's Medical Centre	Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 43394 martin.hewitt@nuh.nhs.uk
Royal Liverpool Children's Hospital, Alder Hey	Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD 44-151-293-3679
Oxford Radcliffe Hospital	Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Kate Wheeler, MD 44-186-522-1066
Royal Marsden - Surrey	Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary Taj, MD 44-20-8642-6011 ext. 1307
Sir James Spence Institute of Child Health at Royal Victoria Infirmary	Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Juliet Hale, MD 44-191-282-4101 j.p.hale@ncl.ac.uk
Southampton General Hospital	Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942
United Kingdom, Northern Ireland
Royal Belfast Hospital for Sick Children	Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk
United Kingdom, Scotland
Royal Aberdeen Children's Hospital	Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Contact: Veronica Neefjes 44-1224-550-217
Royal Hospital for Sick Children	Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD 44-141-201-9309
Royal Hospital for Sick Children	Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD 44-131-536-0426
United Kingdom, Wales
Childrens Hospital for Wales	Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 heidi.traunecker@cardiffandvale.wales.nhs.uk

Sponsors and Collaborators

University Hospitals, Leicester

Investigators

Study Chair:

Ruth Ladenstein, MD

St. Anna Children's Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069191, SIOP-EUROPE-HR-NBL-1, ESIOP, EU-20148
Study First Received:	February 14, 2002
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00030719 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma

Additional relevant MeSH terms:

Melphalan
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Cyclophosphamide
Neuroblastoma
Antibodies, Monoclonal
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Isotretinoin
Dermatologic Agents
Alkylating Agents

Etoposide
Neoplasms by Histologic Type
Mitosis Modulators
Vincristine
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors
Antibodies
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on November 27, 2009