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Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma Clinical research trials and Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma. Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma clinical trial. Human subjects often get the best healthcare possible for their Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma  Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma
Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma
For Condition: disseminated 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, and giving them before surgery, may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.
Details: OBJECTIVES: - Confirm that the management of infants with newly diagnosed stage IV neuroblastoma without MYCN amplification treated with etoposide and carboplatin and cyclophosphamide, doxorubicin, and vincristine followed by surgery does not require intensive high-dose chemotherapy consolidation. - 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 receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses. Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy. Patients with metastatic complete response (CR) undergo surgical resection of primary disease. Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO chemotherapy comprising 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 2 courses. After 2 courses of CADO chemotherapy, patients with metastatic CR undergo surgical resection of primary disease. Patients with residual disease receive 2 additional courses of CADO chemotherapy. Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study. Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease. Patients are followed within 6 months and then annually for 5 years. PROJECTED ACCRUAL: A total of 60 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 neuroblastoma or ganglioneuroblastoma - Metastases to bone, CNS, or pleura/lung by x-ray or CT scan - 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:
BrunoBernardi, Study Chair, Istituto Giannina Gaslini
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Maja Popovic 41-21-314-3567
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
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Catherine Rechnitzer 45-35451368
Istituto Giannina Gaslini *Recruiting*
Genova, , 16148
Italy
Recruiting Bruno Bernardi 39-10-563-6464
National Hospital Oslo University *Recruiting*
Oslo, , 0027
Norway
Recruiting Ingebjorg Storm-Mathisen 47-23-07-45-60
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
Ostra Sjukhuset *Recruiting*
Gothenburg (Goteborg), , 41685
Sweden
Recruiting Jonas Abrahamson 46-31-374-243
Centre Hospitalier Regional de Purpan *Recruiting*
Toulouse, , 31026
France
Recruiting Herve Rubie 33-5-61-491-133
St. Anna Children's Hospital *Recruiting*
Vienna, , A-1090
Austria
Recruiting Ruth Ladenstein 43 1 40470 0
Additional Information:
Study ID Numbers: CDR0000068980; EURO-INF-NB-STUDY-1999-99.3,EU-20125C
Study Start Date:
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025623
Other Disseminated Neuroblastoma Studies:
1. Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
2. Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma
3. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
4. Combination Chemotherapy in Treating Children With Neuroblastoma
5. Isotretinoin With or Without Monoclonal Antibody, Interleukin 2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
Related Studies:
Other disseminated neuroblastoma Clinical Trials
Other Clinical Trials
Other Oslo Clinical Trials
Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma
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