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
NCT ID: NCT00030719
Last Updated: 2014-06-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
175 participants
Study Classification
INTERVENTIONAL
Study Start Date
2001-12-31
Brief Summary
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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.
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.
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Detailed Description
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OBJECTIVES:
* Compare the efficacy of myeloablative therapy with busulfan and melphalan vs carboplatin, etoposide, and melphalan, in terms of 3- and 5-year event-free survival (EFS), progression-free survival (PFS), and overall survival (OS), in patients with high-risk neuroblastoma.
* Compare the 3-year EFS in these patients treated with isotretinoin with or without monoclonal antibody Ch14.18 after myeloablative therapy.
* Determine the response at metastatic sites after induction chemotherapy in these patients.
* Determine the effect of metastatic disease response after induction chemotherapy on EFS, PFS, and OS in these patients.
* Compare the toxicity and episodes of febrile neutropenia in patients treated with induction chemotherapy with or without filgrastim (G-CSF).
* Determine the effect of elective hematopoietic support with G-CSF during induction chemotherapy on peripheral blood stem cell collection in these patients.
* Compare the acute and long-term toxic effects of the 2 myeloablative therapy regimens in these patients.
* Determine the effect of radiotherapy on pre-surgical tumor volume at the primary site on local control, EFS, PFS, and OS in these patients.
* Determine the tolerability of isotretinoin with or without monoclonal antibody Ch14.18 after myeloablative therapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (2 or 3 with MycN amplification vs 4). Patients are randomized to 1 of 8 treatment arms:
Arm I:
* Patients receive induction chemotherapy comprising vincristine IV, carboplatin IV over 1 hour, and etoposide IV over 4 hours on days 1 and 41; vincristine IV and cisplatin IV over 24 hours on days 11, 31, 51, and 71; and vincristine IV on days 21 and 61 and cyclophosphamide IV and etoposide over 4 hours on days 21, 22, 61, and 62. Patients receive filgrastim (G-CSF) subcutaneously on days 3-8, 12-18, 23-28, 32-38, 43-48, 52-58, 63-68, and 72 until peripheral blood stem cell (PBSC) collection.
* Patients undergo PBSC collection beginning on day 80. Patients then undergo surgery on day 95.
* Patients receive myeloablative therapy comprising oral busulfan 4 times daily on days -6 to -3 and melphalan IV over 15 minutes on day -2. Patients undergo PBSC infusion on day 0.
* Patients undergo radiotherapy in 14 fractions over 21 days.
* Beginning within 30 days after radiotherapy, patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for 6 courses.
Arm II:
* Patients receive induction chemotherapy as in arm I, but with no G-CSF. Patients then undergo PBSC collection and surgery as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm I. Patients undergo radiotherapy as in arm I.
* Patients receive oral isotretinoin twice daily on days 1-14 and monoclonal antibody Ch14.18 IV over 8 hours on days 1-5. Treatment repeats every 28 days for 6 courses for isotretinoin and every 28 days for 5 courses for monoclonal antibody Ch14.18.
Arm III:
* Patients receive induction chemotherapy and G-CSF as in arm I. Patients then undergo PBSC collection and surgery as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm I. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin as in arm I.
Arm IV:
* Patients receive induction chemotherapy as in arm II. Patients then undergo PBSC collection and surgery as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm I. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin and monoclonal antibody Ch14.18 as in arm II.
Arm V:
* Patients receive induction chemotherapy and G-CSF as in arm I.
* Patients receive myeloablative therapy comprising carboplatin IV continuously and etoposide IV continuously on days -7 to -4 and melphalan IV over 15 minutes on days -7 to -5. Patients undergo PBSC infusion on day 0.
* Patients undergo radiotherapy as in arm I. Patients receive isotretinoin as in arm I.
Arm VI:
* Patients receive induction chemotherapy as in arm II. Patients receive myeloablative therapy and undergo PBSC infusion as in arm V. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin and monoclonal antibody Ch14.18 as in arm II.
Arm VII:
* Patients receive induction chemotherapy and G-CSF as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm V. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin as in arm I.
Arm VIII:
* Patients receive induction chemotherapy as in arm II. Patients receive myeloablative therapy and undergo PBSC infusion as in arm V. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin and monoclonal antibody Ch14.18 as in arm II.
Patients on all treatment arms are followed every 6 months for 3 years and then annually for 2 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 175 patients per year will be accrued for this study.
* Compare the efficacy of myeloablative therapy with busulfan and melphalan vs carboplatin, etoposide, and melphalan, in terms of 3- and 5-year event-free survival (EFS), progression-free survival (PFS), and overall survival (OS), in patients with high-risk neuroblastoma.
* Compare the 3-year EFS in these patients treated with isotretinoin with or without monoclonal antibody Ch14.18 after myeloablative therapy.
* Determine the response at metastatic sites after induction chemotherapy in these patients.
* Determine the effect of metastatic disease response after induction chemotherapy on EFS, PFS, and OS in these patients.
* Compare the toxicity and episodes of febrile neutropenia in patients treated with induction chemotherapy with or without filgrastim (G-CSF).
* Determine the effect of elective hematopoietic support with G-CSF during induction chemotherapy on peripheral blood stem cell collection in these patients.
* Compare the acute and long-term toxic effects of the 2 myeloablative therapy regimens in these patients.
* Determine the effect of radiotherapy on pre-surgical tumor volume at the primary site on local control, EFS, PFS, and OS in these patients.
* Determine the tolerability of isotretinoin with or without monoclonal antibody Ch14.18 after myeloablative therapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (2 or 3 with MycN amplification vs 4). Patients are randomized to 1 of 8 treatment arms:
Arm I:
* Patients receive induction chemotherapy comprising vincristine IV, carboplatin IV over 1 hour, and etoposide IV over 4 hours on days 1 and 41; vincristine IV and cisplatin IV over 24 hours on days 11, 31, 51, and 71; and vincristine IV on days 21 and 61 and cyclophosphamide IV and etoposide over 4 hours on days 21, 22, 61, and 62. Patients receive filgrastim (G-CSF) subcutaneously on days 3-8, 12-18, 23-28, 32-38, 43-48, 52-58, 63-68, and 72 until peripheral blood stem cell (PBSC) collection.
* Patients undergo PBSC collection beginning on day 80. Patients then undergo surgery on day 95.
* Patients receive myeloablative therapy comprising oral busulfan 4 times daily on days -6 to -3 and melphalan IV over 15 minutes on day -2. Patients undergo PBSC infusion on day 0.
* Patients undergo radiotherapy in 14 fractions over 21 days.
* Beginning within 30 days after radiotherapy, patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for 6 courses.
Arm II:
* Patients receive induction chemotherapy as in arm I, but with no G-CSF. Patients then undergo PBSC collection and surgery as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm I. Patients undergo radiotherapy as in arm I.
* Patients receive oral isotretinoin twice daily on days 1-14 and monoclonal antibody Ch14.18 IV over 8 hours on days 1-5. Treatment repeats every 28 days for 6 courses for isotretinoin and every 28 days for 5 courses for monoclonal antibody Ch14.18.
Arm III:
* Patients receive induction chemotherapy and G-CSF as in arm I. Patients then undergo PBSC collection and surgery as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm I. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin as in arm I.
Arm IV:
* Patients receive induction chemotherapy as in arm II. Patients then undergo PBSC collection and surgery as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm I. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin and monoclonal antibody Ch14.18 as in arm II.
Arm V:
* Patients receive induction chemotherapy and G-CSF as in arm I.
* Patients receive myeloablative therapy comprising carboplatin IV continuously and etoposide IV continuously on days -7 to -4 and melphalan IV over 15 minutes on days -7 to -5. Patients undergo PBSC infusion on day 0.
* Patients undergo radiotherapy as in arm I. Patients receive isotretinoin as in arm I.
Arm VI:
* Patients receive induction chemotherapy as in arm II. Patients receive myeloablative therapy and undergo PBSC infusion as in arm V. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin and monoclonal antibody Ch14.18 as in arm II.
Arm VII:
* Patients receive induction chemotherapy and G-CSF as in arm I. Patients receive myeloablative therapy and undergo PBSC infusion as in arm V. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin as in arm I.
Arm VIII:
* Patients receive induction chemotherapy as in arm II. Patients receive myeloablative therapy and undergo PBSC infusion as in arm V. Patients undergo radiotherapy as in arm I. Patients receive isotretinoin and monoclonal antibody Ch14.18 as in arm II.
Patients on all treatment arms are followed every 6 months for 3 years and then annually for 2 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 175 patients per year will be accrued for this study.
Conditions
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Neuroblastoma
Study Design
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Allocation Method
RANDOMIZED
Primary Study Purpose
TREATMENT
Interventions
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filgrastim
Intervention Type
BIOLOGICAL
monoclonal antibody Ch14.18
Intervention Type
BIOLOGICAL
busulfan
Intervention Type
DRUG
carboplatin
Intervention Type
DRUG
cyclophosphamide
Intervention Type
DRUG
etoposide
Intervention Type
DRUG
isotretinoin
Intervention Type
DRUG
melphalan
Intervention Type
DRUG
vincristine sulfate
Intervention Type
DRUG
bone marrow ablation with stem cell support
Intervention Type
PROCEDURE
conventional surgery
Intervention Type
PROCEDURE
peripheral blood stem cell transplantation
Intervention Type
PROCEDURE
radiation therapy
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion 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
* 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
Minimum Eligible Age
1 Year
Maximum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Leicester
OTHER
Sponsor Role
lead
Principal Investigators
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Ruth Ladenstein, MD
Role: STUDY_CHAIR
St. Anna Kinderkrebsforschung
Locations
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St. Anna Children's Hospital
Vienna, , Austria
Site Status
RECRUITING
Universitair Ziekenhuis Gent
Ghent, , Belgium
Site Status
RECRUITING
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, , Denmark
Site Status
RECRUITING
Institut Gustave Roussy
Villejuif, , France
Site Status
RECRUITING
Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Site Status
RECRUITING
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Site Status
RECRUITING
Fondazione Istituto Nazionale dei Tumori
Milan, , Italy
Site Status
RECRUITING
Rikshospitalet University Hospital
Oslo, , Norway
Site Status
RECRUITING
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
Lisbon, , Portugal
Site Status
RECRUITING
Hospital Universitario La Fe
Valencia, , Spain
Site Status
RECRUITING
Karolinska University Hospital - Solna
Stockholm, , Sweden
Site Status
RECRUITING
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Site Status
RECRUITING
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Site Status
RECRUITING
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Site Status
RECRUITING
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Site Status
RECRUITING
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Site Status
RECRUITING
Leicester Royal Infirmary
Leicester, England, United Kingdom
Site Status
RECRUITING
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Site Status
RECRUITING
Middlesex Hospital
London, England, United Kingdom
Site Status
RECRUITING
Great Ormond Street Hospital for Children
London, England, United Kingdom
Site Status
RECRUITING
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Site Status
RECRUITING
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Site Status
RECRUITING
Queen's Medical Centre
Nottingham, England, United Kingdom
Site Status
RECRUITING
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Site Status
RECRUITING
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Site Status
RECRUITING
Southampton General Hospital
Southampton, England, United Kingdom
Site Status
RECRUITING
Royal Marsden - Surrey
Sutton, England, United Kingdom
Site Status
RECRUITING
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Site Status
RECRUITING
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Site Status
RECRUITING
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Site Status
RECRUITING
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Site Status
RECRUITING
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Site Status
RECRUITING
Countries
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Austria
Belgium
Denmark
France
Ireland
Israel
Italy
Norway
Portugal
Spain
Sweden
Switzerland
United Kingdom
Facility Contacts
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Ruth Ladenstein, MD
Role: primary
43-1-404-700
Henrik Schroder, MD
Role: primary
45-89-49-44-44
D. Valteau-Couanet
Role: primary
33-1-4211-4339
Ingebjorg Storm-Mathisen, MD
Role: primary
47-23-07-45-60
Victoria Castel
Role: primary
34-96-386-2700
Pamela Kearns, MD
Role: primary
44-117-342-8260
Amos Burke, MD
Role: primary
44-1223-348-151
Heather P. McDowell, MD
Role: primary
44-151-293-3679
Ananth Shankar, MD
Role: primary
44-20-7380-9300 ext. 9950
Kate Wheeler, MD
Role: primary
44-186-522-1066
Janice A. Kohler, MD, FRCP
Role: primary
44-23-8079-6942
Mary Taj, MD
Role: primary
44-20-8642-6011 ext. 1307
Veronica Neefjes
Role: primary
44-1224-550-217
W. Hamish Wallace, MD
Role: primary
44-131-536-0426
Milind D. Ronghe, MD
Role: primary
44-141-201-9309
References
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Ladenstein R, Valteau-Couanet D, Brock P, Yaniv I, Castel V, Laureys G, Malis J, Papadakis V, Lacerda A, Ruud E, Kogner P, Garami M, Balwierz W, Schroeder H, Beck-Popovic M, Schreier G, Machin D, Potschger U, Pearson A. Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study. J Clin Oncol. 2010 Jul 20;28(21):3516-24. doi: 10.1200/JCO.2009.27.3524. Epub 2010 Jun 21.
Reference Type
RESULT
Veal GJ, Nguyen L, Paci A, Riggi M, Amiel M, Valteau-Couanet D, Brock P, Ladenstein R, Vassal G. Busulfan pharmacokinetics following intravenous and oral dosing regimens in children receiving high-dose myeloablative chemotherapy for high-risk neuroblastoma as part of the HR-NBL-1/SIOPEN trial. Eur J Cancer. 2012 Nov;48(16):3063-72. doi: 10.1016/j.ejca.2012.05.020. Epub 2012 Jun 26.
Reference Type
DERIVED
Other Identifiers
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SIOP-EUROPE-HR-NBL-1
Identifier Type: -
Identifier Source: secondary_id
ESIOP
Identifier Type: -
Identifier Source: secondary_id
EU-20148
Identifier Type: -
Identifier Source: secondary_id
CDR0000069191
Identifier Type: -
Identifier Source: org_study_id
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