Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma.
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|ClinicalTrials.gov Identifier: NCT00025597|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
|First Submitted Date ICMJE||October 11, 2001|
|First Posted Date ICMJE||January 27, 2003|
|Last Update Posted Date||September 17, 2013|
|Study Start Date ICMJE||July 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00025597 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma.|
|Official Title ICMJE||European Infant Neuroblastoma Study - Unresectable Tumors (MYCN Not Amplified)|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug 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.
OUTLINE: This is a multicenter study. Patients are stratified according to symptomatic spinal cord involvement (yes vs no).
Patients without evidence of symptomatic spinal cord compression receive vincristine IV on day 1 and cyclophosphamide IV on days 1-5. Treatment repeats every 14 days for 2 courses. Patients eligible for surgery undergo surgical resection and then are removed from the study.
Patients ineligible for surgery after 2 courses of initial chemotherapy, but with at least 25% response to initial chemotherapy, receive 2 additional courses of vincristine and cyclophosphamide. Patients eligible for surgery undergo surgical resection and then are removed from the study.
Patients ineligible for surgery after 2 additional courses of initial chemotherapy or with disease progression 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 eligible for surgery undergo surgical resection and then are removed from the study.
Patients who remain ineligible for surgery or with disease progression after etoposide and carboplatin 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 2 courses. Patients then undergo surgical resection or biopsy.
Patients with symptomatic spinal cord compression receive initial treatment with etoposide and carboplatin as above. Patients with improved symptoms and resectable disease after initial chemotherapy undergo surgical resection or biopsy. Patients who remain ineligible for surgery or with no improvement in symptoms after initial chemotherapy receive cyclophosphamide, doxorubicin, and vincristine as above. Patients then undergo surgical resection or biopsy.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms||Not Provided|
|Publications *||Rubie H, De Bernardi B, Gerrard M, Canete A, Ladenstein R, Couturier J, Ambros P, Munzer C, Pearson AD, Garaventa A, Brock P, Castel V, Valteau-Couanet D, Holmes K, Di Cataldo A, Brichard B, Mosseri V, Marquez C, Plantaz D, Boni L, Michon J. Excellent outcome with reduced treatment in infants with nonmetastatic and unresectable neuroblastoma without MYCN amplification: results of the prospective INES 99.1. J Clin Oncol. 2011 Feb 1;29(4):449-55. doi: 10.1200/JCO.2010.29.5196. Epub 2010 Dec 20.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Actual Study Completion Date||February 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||up to 1 Year (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Austria, Belgium, Denmark, France, Italy, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00025597|
|Other Study ID Numbers ICMJE||CDR0000068977
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||European Infant Neuroblastoma Study Group - 1999|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||November 2001|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP