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NeuroblastomaNCT00526318

Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

A study testing filgrastim, carboplatin and cisplatin in people with Neuroblastoma, run by German Society for Pediatric Oncology and Hematology GPOH gGmbH at 68 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Neuroblastoma
What is being tested?
filgrastim, carboplatin and cisplatin
Type of treatment
Surgery or procedure
How many people
360 participants
Where
68 sitesin 2 countries
Study dates
Jan 2007to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Diagnosis of neuroblastoma according to any of the following criteria:
  • Histological diagnosis from tumor tissue
  • Presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine
  • High-risk disease, meeting 1 of the following criteria:
  • Stage 4 disease, regardless of the MYCN status (1-21 years of age)
  • Stage 1-3 or 4S disease with MYCN amplification (6 months -21 years of age)

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception (hormonal contraception or intra-uterine device [IUD])

PRIOR CONCURRENT THERAPY:

  • No concurrent participation in another clinical trial that would preclude the interventions or outcome assessment of this clinical trial
  • No other concurrent anticancer therapy

Trial locations and contacts

68 sites in 2 countries.

68 sites in 2 countries

Germany63 sites, 63 recruiting

  • Kinderklinik - Universitaetsklinikum Aachen

    Aachen, D-52074

    R. Mertens, MD, PhD, 49-241-808-9902, rmertens@ukaachen.de

    Recruiting

  • Klinikum Augsburg

    Augsburg, DOH-86156

    Astrid Gnekow, 49-821-400-3603

    Recruiting

  • Klinikum Bayreuth

    Bayreuth, D-95445

    T. Rupprecht, 49-921-400-1400

    Recruiting

  • Helios Klinikum Berlin

    Berlin, 13125

    Lothar Schweigerer, MD, 49-30-9401-2345

    Recruiting

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

    Gunter Henze, 49-30-450-660-31

    Recruiting

  • Evangelisches Krankenhauus Bielfeld

    Biefeld, 33617

    N. Jorch, MD, 49-52-177-278-050

    Recruiting

  • Kinderklinik der Universitaet Bonn

    Bonn, D-53113

    Udo Bode, MD, 49-228-2873-3215, udo.bode@ukb.uni-bonn.de

    Recruiting

  • Staedtisches Klinikum - Howedestrase

    Braunschweig, 38118

    Wolfgang Eberl, MD, 49-531-595-1222, w.eberl@kliniklum-braunschweig.de

    Recruiting

  • Klinikum Bremen-Mitte

    Bremen, D-28205

    Arnulf Pekrun, MD, PhD, 49-421-497-3656, arnulf.pekrun@klinikum-bremen-mitte.de

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, D-09116

    Krause, MD, 49-371-3332-4124

    Recruiting

  • Klinikum Coburg

    Coburg, 96450

    Roland Frank, MD, 49-9561-22-5547

    Recruiting

  • Children's Hospital

    Cologne, D-50924

    Frank Berthold, MD, 49-221-478-4380, frank.berthold@uk-koeln.de

    Recruiting

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, D-03048

    D Mobius, MD, 49-355-462336

    Recruiting

  • Vestische Kinderklinik

    Datteln, 45704

    W. Andler, MD, 49-023-63-9750, w.andler@kinderklinik-datteln.de

    Recruiting

  • Klinikum Lippe - Detmold

    Detmold, D-32756

    Klaus Wesseler, MD, 49-523-172-4511

    Recruiting

  • Klinikum Dortmund

    Dortmund, D-44137

    Dominik T. Schneider, MD, 49-231-953-2-1670, dominik.schneider@klinikumdo.de

    Recruiting

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

    M. Suttorp, MD, 49-351-458-0, meinolf.suttorp@uniklinikum-dresden.de

    Recruiting

  • Klinikum Duisburg

    Duisburg, D-47055

    Ruef, MD, 49-203-733-2421

    Recruiting

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, D-40225

    Arndt Borkhardt, 49-211-311-7990

    Recruiting

  • Helios Klinikum Erfurt

    Erfurt, 99089

    Axel Sauerbrey, MD, 49-361-781-3729, asauerbrey@erfurt.helios-kliniken.de

    Recruiting

  • Universitaets - Kinderklinik

    Erlangen, 91054

    W. Holter, MD, 49-9131-853-3118

    Recruiting

  • Universitaetsklinikum Essen

    Essen, D-45147

    Bernhard Kremens, MD, 49-201-723-2453

    Recruiting

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

    Thomas Klingebiel, MD, 49-69-6301-5094, thomas.klingebiel@kgu.de

    Recruiting

  • Universitaetskinderklinik - Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

    Charlotte Niemeyer, MD, 49-761-270-4506, charlotte.niemeyer@uniklinik-freiburg.de

    Recruiting

  • Kinderklinik

    Giessen, D-35385

    Alfred Reiter, MD, 49-641-994-3420

    Recruiting

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

    M. Lakomek, MD, 49-551-398-600

    Recruiting

  • Universitats - Kinderklinik

    Greiswald, 17487

    James F. Beck, MD, 49-383-486-6325, beck@uni-greifswald.de

    Recruiting

  • Universitaetsklinikum Halle

    Halle, D-06097

    Dieter Koerholz, MD, 49-345-557-2387

    Recruiting

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, D-06110

    G. Guenther, MD, 49-345-482-50

    Recruiting

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

    Rudolf Erttmann, MD, 49-40-4717-4270, erttmann@uke.uni-hamburg.de

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, D-30625

    Karl Welte, MD, 49-511-532-6710, welte.karl.h@mh-hannover.de

    Recruiting

  • Universitaets-Kinderklinik Heidelberg

    Heidelberg, D-69120

    Andreas E. Kulozik, MD, PhD, 49-6221-564-555, andreas.kulozik@med.uni-heidelberg.de

    Recruiting

  • Gemeinschaftskrankenhaus

    Herdecke, 58313

    Christoph Tautz, MD, 49-2330-62-3914, ctautz@yahoo.de

    Recruiting

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421

    Norbert Graf, 49-6841-162-4000

    Recruiting

  • Universitaets - Kinderklinik

    Jena, D-07745

    Felix Zintl, MD, 49-3641-938-270

    Recruiting

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

    A. Leipold, 49-721-974-3311

    Recruiting

  • Klinikum Kassel

    Kassel, D-34125

    Martina Rodehueser, MD, 49-561-980-3066

    Recruiting

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

    A. Claviez, MD, 49-431-597-1622, a.claviez@pediatrics.uni-kiel.de

    Recruiting

  • Klinikum Kemperhof Koblenz

    Koblenz, D-56065

    M. Rister, MD, 49-261-499-2602

    Recruiting

  • Klinikum Krefeld GmbH

    Krefeld, D-47805

    S. Volpel, MD, 49-2151-32-2375

    Recruiting

  • Universitaets - Kinderklinik - Luebeck

    Lübeck, D-23538

    Peter P. Bucsky, MD, 49-451-500-2956, bucsky@paedia.ukl.mu-luebeck.de

    Recruiting

  • St. Annastift Krankenhaus

    Ludwigshafen, 67065

    Barbara Selle, MD, 49-621-5702-4449

    Recruiting

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, D-39120

    P. Vorwerk, MD, 49-394-672-791

    Recruiting

  • Johannes Gutenberg University

    Mainz, D-55101

    P. Gutjahr, MD, 49-6131-17-2112

    Recruiting

  • Staedtisches Klinik - Kinderklinik

    Mannheim, D-68167

    M. Duerken, 49-621-383-2243

    Recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg

    Marburg, D-35043

    H. Christiansen, MD, 49-6421-286-2671

    Recruiting

  • Klinikum Minden

    Minden, D-32423

    Bernhard Erdlenbruch, MD, 49-57-1801-4601, bernhard.erdlenbruch@klinikum-minden.de

    Recruiting

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

    Stefan Burdach, MD, PhD, 49-89-3068-2352

    Recruiting

  • Dr. von Haunersches Kinderspital der Universitaet Muenchen

    Munich, D-80337

    Irene Schmid, MD, 49-89-5160-7978

    Recruiting

  • Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

    Münster, D-48149

    Heribert F. Juergens, MD, 49-251-834-7742, jurgh@uni-muenster.de

    Recruiting

  • Klinikum Neubrandenburg

    Neubrandenburg, 17036

    H. J. Feickert, MD, PhD, 49-395-775-2901, feickerthj@dbk-nb.de

    Recruiting

  • Cnopf'sche Kinderklinik

    Nuremberg, 90419

    W. Scheurlen, 49-911-334-002

    Recruiting

  • Klinikum Oldenburg

    Oldenburg, 26133

    Hermann Mueller, MD, 49-441-403-2013, mueller.hermann@klinikum-oldenburg.de

    Recruiting

  • Klinik St. Hedwig-Kinderklinik

    Regensburg, 93049

    Ove Peters, 49-941-369-5404

    Recruiting

  • Kinderklinik - Universitaetsklinikum Rostock

    Rostock, D-18057

    Carl Friedrich Classen, MD, PD, 49-381-494-0, carl-friedrich.classen@med.uni-rostock.de

    Recruiting

  • Johanniter-Kinderklinik

    Sankt Augustin, 53757

    Roswitha Dickerhoff, MD, 49-22-41-2491, roswitha.dickerhoft@uni-bonn.de

    Recruiting

  • Kinderklink Siegen Deutsches Rotes Kreuz

    Siegen, D-57072

    Rainer Burghard, MD, 49-271-2345-0, rainer.burghard@drk-kinderklinik.de

    Recruiting

  • Olgahospital

    Stuttgart, D-70176

    Stefan Bielack, MD, 49-711-99-24-61, st.bielack@olgahospital.de

    Recruiting

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

    Wolfgang Rauh, MD, 49-651-947-2654

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

    Rupert Handgretinger, MD, 49-7071-298-2087

    Recruiting

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89075

    Klaus M. Debatin, MD, 49-731-5002-7790, klaus-michael.debatin@medizin.uni-ulm.de

    Recruiting

  • Helios Kliniken Wuppertal University Hospital

    Wuppertal, D-42283

    K. Sinha, MD, 49-202-896-2441

    Recruiting

  • Universitaets - Kinderklinik Wuerzburg

    Würzburg, D-97080

    P. G. Schlegel, MD, 49-931-201-27-831, schlegel@mail.uni-wuerzburg.de

    Recruiting

Other trials in Germany

Switzerland5 sites, 5 recruiting

  • Kantonsspital Aarau

    Aarau, CH-5001

    R. Angst, 41-62-838-4906

    Recruiting

  • Universitaets-Kinderspital beider Basel

    Basel, CH-4005

    Thomas Kuhne, MD, 41-61-685-6565, thomas.kuehne@ukbb.ch

    Recruiting

  • Kinderspital Luzern

    Lucerne, CH-6000

    U. Caflisch, MD, 41-41-205-11-11

    Recruiting

  • Ostschweizer Kinderspital

    Sankt Gallen, CH-9006

    Jeanette Greiner, MD, 41-71-243-13-60, jeanette.greiner@kispisg.ch

    Recruiting

  • University Children's Hospital

    Zurich, CH-8032

    Felix Niggli, MD, 41-44-266-7823

    Recruiting

Other trials in Switzerland

About this study

Official title: Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.

PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the event-free survival of pediatric patients with high-risk neuroblastoma treated with standard induction chemotherapy vs topotecan hydrochloride-containing induction chemotherapy followed by myeloablative autologous stem cell transplantation and consolidation therapy with isotretinoin.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare early response (complete response, very good partial response, partial response, mixed response, stable disease, and progression/relapse) after 2 courses of standard vs experimental induction chemotherapy (or after 60 days if the second course is not yet finished).
  • Compare response to standard vs experimental induction chemotherapy before autologous stem cell transplantation (or after 280 days if induction chemotherapy is not yet finished).
  • Compare the toxicity of standard vs experimental induction chemotherapy during courses 1 and 2 and the frequency of ≥ grade 3 toxicity during the last 6 courses of induction chemotherapy.
  • Compare the extent of initial surgery and best surgery (biopsy vs incomplete resection vs macroscopic complete resection) and the frequency of complications related to surgery (e.g., nephrectomy, bleeding, infection, or intestinal obstruction).
  • Compare the acute and long-term side effects of external-beam radiotherapy.
  • Correlate the activity of MIBG and whole-body radiation dose.
  • Collect and store tumor material in the tumor bank for future evaluation of other molecular markers (MYCN and status of chromosome 1p and 11q) and prognostic significant gene signatures.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage, lactate dehydrogenase (LDH) status, MYCN status, and age at diagnosis (stage 4 disease; LDH not elevated; any MYCN status; age at diagnosis 1-21 years vs stage 4 disease; LDH elevated; any MYCN status; age at diagnosis ≥ 1 but < 2 years vs stage 4 disease; LDH elevated; any MYCN status; age at diagnosis 2-21 years vs localized disease; MYCN amplification; age at diagnosis ≥ 6 months)

  • Induction chemotherapy: Patients are randomized to 1 of 2 induction chemotherapy arms.
  • Arm I (standard): Patients receive N5 chemotherapy comprising cisplatin IV continuously over 96 hours and etoposide phosphate IV continuously over 96 hours on days 1-4 and vindesine IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 9 and continuing until blood counts recover. Patients then receive N6 chemotherapy comprising vincristine IV over 1 hour on days 1 and 8, dacarbazine IV over 1 hour on days 1-5, ifosfamide IV continuously over 120 hours on days 1-5, and doxorubicin hydrochloride IV over 4 hours on days 6 and 7. Patients also receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Treatment with N5 and N6 chemotherapy alternates every 21 days for 6 courses (N5 chemotherapy is given in courses 1, 3, and 5 and N6 chemotherapy is given in courses 2, 4, and 6).
  • Arm II (experimental): Patients receive N8 chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-7, topotecan hydrochloride IV continuously over 168 hours on days 1-7, and etoposide phosphate IV over 1 hour on days 8-10. Patients also receive G-CSF SC once daily beginning on day 12 and continuing until blood counts recover. Treatment with N8 chemotherapy repeats every 21 days for 2 courses. Patients then receive N5 chemotherapy alternating with N6 chemotherapy as in arm I.
  • Surgery: Patients may undergo secondary surgery after completion of 4 or 6 courses of induction chemotherapy but prior to radiotherapy.
  • Radiotherapy (131I-MIBG therapy and external-beam radiotherapy [EBRT]): Patients with active residual primary tumor after the completion of induction chemotherapy undergo ^131I-MIBG therapy* prior to autologous stem cell transplantation (ASCT) and EBRT after ASCT.

NOTE: *Patients with MIBG negative neuroblastoma at initial diagnosis will only receive EBRT.

  • Myeloablative ASCT: Patients receive melphalan IV over 30 minutes on days -8 to -5, etoposide phosphate IV over 4 hours on day -4, and carboplatin IV over 1 hour on days -4 to -2. Patients undergo reinfusion of CD34+ stem cells on day 0. Patients also receive G-CSF SC or IV over 4 hours once daily beginning on day 2 and continuing until blood counts recover.
  • Consolidation therapy (isotretinoin)*: Beginning 30 days after ASCT, patients receive oral isotretinoin once daily on days 1-14. Treatment repeats every 28 days for up to 6 courses. Beginning 3 months later, patients receive an additional 3 courses of isotretinoin.

NOTE: *Isotretinoin must not be given concurrently with radiotherapy

After completion of study treatment, patients are followed every 6 weeks for 1 year, every 3 months for 4 years, and then every 6 months thereafter.

Conditions
Neuroblastoma
Being tested
filgrastim, carboplatin, cisplatin, cyclophosphamide, dacarbazine
Keywords
localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, disseminated neuroblastoma
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

Secondary outcomes (9)

  1. Overall survival (OS)

  2. Impact of well established clinical and molecular risk factors on EFS and OS

  3. Early response, measured after 2 courses of induction chemotherapy

  4. Response to induction therapy, measured before autologous stem cell transplantation

  5. Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy

  6. Impact of the extent of initial and best surgery on outcome and frequency of complications

  7. Acute and late toxicity of radiotherapy

  8. Correlation of MIBG activity with whole-body radiation dose

  9. Molecular markers (MYCN and status of chromosome 1p and 11q)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00526318
Sponsor's protocol ID
GPOH-NB2004-HR
Other IDs
CDR0000564820, UNI-KOELN-161, EU-20661
Status last verified
Jul 2015
First submitted
5 Sep 2007
Last updated
16 Jul 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing filgrastim, carboplatin and cisplatin in people with Neuroblastoma, run by German Society for Pediatric Oncology and Hematology GPOH gGmbH at 68 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00526318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.

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