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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma  Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma
Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma
For Condition: disseminated neuroblastoma,stage 4S neuroblastoma
Status: Recruiting
Sponsor(s): European Infant Neuroblastoma Study Group - 1999 ,
Synopsis: 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 chemotherapyregimens in treating infants who have newly diagnosed neuroblastoma.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed stage IV or IVS neuroblastoma or ganglioneuroblastoma - Metastases confined to marrow, skin, nodes, or liver - No metastases to bone (radiologic bone lesions in skeleton), CNS, pleura, or lung - No MYCN amplification (i.e., fewer than 10 copies) PATIENT CHARACTERISTICS: Age: - Under 12 months at diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaryGerrard, Study Chair, Children's Hospital - Sheffield
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Catherine Rechnitzer 45-35451368
National Hospital Oslo University *Recruiting*
Oslo, , 0027
Norway
Recruiting Ingebjorg Storm-Mathisen 47-23-07-45-60
Ostra Sjukhuset *Recruiting*
Gothenburg (Goteborg), , 41685
Sweden
Recruiting Jonas Abrahamson 46-31-374-243
Hospital Universitario LA FE *Recruiting*
Valencia, , 46009
Spain
Recruiting Adela Canete 36-96-397727
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa *Recruiting*
Lisboa, , 1099-023 Codex
Portugal
Recruiting Ana De Lacerda 351-21-726-0429
Centre Hospitalier Regional de Purpan *Recruiting*
Toulouse, , 31026
France
Recruiting Herve Rubie 33-5-61-491-133
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Maja Popovic 41-21-314-3567
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Genevieve Laureys 32-9-240-21-11
Bristol Royal Hospital for Children *Recruiting*
Bristol, England, BS2 8BJ
United Kingdom
Recruiting Annabel Foot 44-117-921-5411
Children's Hospital - Sheffield *Recruiting*
Sheffield, England, S10 2TH
United Kingdom
Recruiting Mary Gerrard 00-44-0114-271-7229
St. Anna Children's Hospital *Recruiting*
Vienna, , A-1090
Austria
Recruiting Ruth Ladenstein 43 1 40470 0
Istituto Giannina Gaslini *Recruiting*
Genova, , 16148
Italy
Recruiting Bruno Bernardi 39-10-563-6464
Additional Information:
Study ID Numbers: CDR0000068979; EU-20125B,EURO-INF-NB-STUDY-1999-99.2
Study Start Date:
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025610
Other Stage 4s Neuroblastoma Studies:
1. 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
2. Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
3. Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma
4. Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
5. Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma
Related Studies:
Other stage 4S neuroblastoma Clinical Trials
Other England Clinical Trials
Other Bristol Clinical Trials
Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma
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