Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00025610|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
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 or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate||Phase 2|
- Confirm that the outcome for infants with newly diagnosed stage IV or IVS neuroblastoma without MYCN amplification is not altered by treatment with etoposide and carboplatin followed by cyclophosphamide, doxorubicin, and vincristine.
- Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.
- Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.
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.
- VP-CARBO chemotherapy: Patients receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses. Patients with no response receive CADO chemotherapy.
- CADO chemotherapy: Patients receive cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for a maximum of 4 courses.
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Study Completion Date :||March 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025610
|St. Anna Children's Hospital|
|Vienna, Austria, A-1090|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Copenhagen, Denmark, 2100|
|Centre Hospitalier Regional de Purpan|
|Toulouse, France, 31026|
|Istituto Giannina Gaslini|
|Genoa, Italy, 16148|
|Rikshospitalet University Hospital|
|Oslo, Norway, 0027|
|Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.|
|Lisboa, Portugal, 1099-023 Codex|
|Hospital Universitario LA FE|
|Valencia, Spain, 46009|
|Gothenburg, Sweden, 41685|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|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|