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| Sponsored by: |
European Infant Neuroblastoma Study Group - 1999 |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025610 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.
| Condition | Intervention | Phase |
|
Neuroblastoma |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate |
Phase II |
| MedlinePlus related topics: | Cancer Neuroblastoma |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Carboplatin Etoposide Vincristine sulfate Vincristine Etoposide phosphate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN Not Amplified |
| Study Start Date: | July 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to age (under 1 month vs over 1 month).
Infants less than 1 month of age are further stratified according to Philadelphia score (less than 1 vs at least 1). Infants over 1 month of age are also further stratified according to Philadelphia score (less than 2 vs at least 2).
Infants under 1 month of age with Philadelphia score of less than 1 and infants over 1 month of age with Philadelphia score of less than 2 undergo observation only. Infants under 1 month of age with Philadelphia score of at least 1 and infants over 1 month of age with Philadelphia score of at least 2 receive VP-CARBO chemotherapy.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study within 4 years.
Eligibility
| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed stage IV or IVS neuroblastoma or ganglioneuroblastoma
Metastases confined to marrow, skin, nodes, or liver
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| Austria | |||||
| St. Anna Children's Hospital | |||||
| Vienna, Austria, A-1090 | |||||
| Belgium | |||||
| Universitair Ziekenhuis Gent | |||||
| Ghent, Belgium, B-9000 | |||||
| Denmark | |||||
| Rigshospitalet | |||||
| Copenhagen, Denmark, 2100 | |||||
| France | |||||
| Centre Hospitalier Regional de Purpan | |||||
| Toulouse, France, 31026 | |||||
| Italy | |||||
| Istituto Giannina Gaslini | |||||
| Genoa, Italy, 16148 | |||||
| Norway | |||||
| Rikshospitalet University Hospital | |||||
| Oslo, Norway, 0027 | |||||
| Portugal | |||||
| Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A. | |||||
| Lisboa, Portugal, 1099-023 Codex | |||||
| Spain | |||||
| Hospital Universitario LA FE | |||||
| Valencia, Spain, 46009 | |||||
| Sweden | |||||
| Ostra Sjukhuset | |||||
| Gothenburg, Sweden, 41685 | |||||
| Switzerland | |||||
| Centre Hospitalier Universitaire Vaudois | |||||
| Lausanne, Switzerland, CH-1011 | |||||
| United Kingdom, England | |||||
| Bristol Royal Hospital for Children | |||||
| Bristol, England, United Kingdom, BS2 8BJ | |||||
| Children's Hospital - Sheffield | |||||
| Sheffield, England, United Kingdom, S10 2TH | |||||
| European Infant Neuroblastoma Study Group - 1999 |
| Study Chair: | Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH | Children's Hospital - Sheffield |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068979, EURO-INF-NB-STUDY-1999-99.2, EU-20125B |
| First Received: | October 11, 2001 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00025610 |
| Health Authority: | United States: Federal Government |
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