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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030719
First received: February 14, 2002
Last updated: June 23, 2014
Last verified: August 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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   
Institute of Child Health at University of Bristol Recruiting
Bristol, England, United Kingdom, BS2 8AE
Contact: Pamela Kearns, MD    44-117-342-8260      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Amos Burke, MD    44-1223-348-151      
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   
Royal Liverpool Children's Hospital, Alder Hey Recruiting
Liverpool, England, United Kingdom, L12 2AP
Contact: Heather P. McDowell, MD    44-151-293-3679      
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   
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   
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   
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   
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Kate Wheeler, MD    44-186-522-1066      
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   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Janice A. Kohler, MD, FRCP    44-23-8079-6942      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary Taj, MD    44-20-8642-6011 ext. 1307      
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   
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
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Royal Hospital for Sick Children Recruiting
Glasgow, Scotland, United Kingdom, G3 8SJ
Contact: Milind D. Ronghe, MD    44-141-201-9309      
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 of Leicester
Investigators
Study Chair: Ruth Ladenstein, MD St. Anna Kinderkrebsforschung
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00030719     History of Changes
Other Study ID Numbers: CDR0000069191, SIOP-EUROPE-HR-NBL-1, ESIOP, EU-20148
Study First Received: February 14, 2002
Last Updated: June 23, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
localized unresectable neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Antibodies
Antibodies, Monoclonal
Cyclophosphamide
Isotretinoin
Lenograstim
Vincristine
Adjuvants, Immunologic
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014