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Sponsored by: |
European Infant Neuroblastoma Study Group - 1999 |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025610 |
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 |
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.
Treatment repeats every 21 days for 2 courses. Patients with no response receive CADO chemotherapy.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study within 4 years.
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
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 |
Study Chair: | Mary P. Gerrard, MBChB, FRCP, FRCPCH | Children's Hospital - Sheffield |
Study ID Numbers: | CDR0000068979, EURO-INF-NB-STUDY-1999-99.2, EU-20125B |
Study First Received: | October 11, 2001 |
Last Updated: | July 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00025610 History of Changes |
Health Authority: | United States: Federal Government |
disseminated neuroblastoma stage 4S neuroblastoma |
Neuroectodermal Tumors, Primitive Immunologic Factors Vincristine Antimitotic Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Etoposide phosphate Neuroblastoma Doxorubicin Anti-Bacterial Agents |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neuroblastoma Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Mitosis Modulators Vincristine |
Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |