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. The completion date has passed and the status has not been verified in more than two years.
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
  • Mean number of febrile events during induction

Secondary Outcome Measures:
  • Response rate assessed by the International Neuroblastoma Response Criteria after 4 and 8 induction chemotherapy courses
  • Event-free survival at 5 years
  • Overall survival
  • Toxicity
  • Biological factors (i.e., MycNM amplification, 1p deletion, ploidy, 17 q+, CD44, and Trk-A)
  • Serum concentrations of lactic dehydrogenase, ferritin, neurone specific enolase
  • Urinary catecholamines at diagnosis

Estimated Enrollment: 175
Study Start Date: December 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Vienna, Austria, A-1090
Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Denmark
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, Denmark, DK-8000
France
Institut Gustave Roussy
Villejuif, France, F-94805
Ireland
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
Israel
Schneider Children's Medical Center of Israel
Petah-Tikva, Israel, 49202
Italy
Fondazione Istituto Nazionale dei Tumori
Milan, Italy, 20133
Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
Lisbon, Portugal, 1099-023 Codex
Spain
Hospital Universitario La Fe
Valencia, Spain, 46009
Sweden
Karolinska University Hospital - Solna
Stockholm, Sweden, S-171 76
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
University of Leicester
Investigators
Study Chair: Ruth Ladenstein, MD St. Anna Kinderkrebsforschung
  More Information

Publications:
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

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

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Melphalan
Busulfan
Carboplatin
Vincristine
Etoposide
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Lenograstim
Isotretinoin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on January 19, 2017