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Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma.

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025597
First received: October 11, 2001
Last updated: September 16, 2013
Last verified: November 2001

October 11, 2001
September 16, 2013
July 1999
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Complete list of historical versions of study NCT00025597 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma.
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.

OBJECTIVES:

  • Determine the survival and morbidity of infants with newly diagnosed stage II or III unresectable neuroblastoma without MYCN amplification treated with vincristine and cyclophosphamide, etoposide and carboplatin, and cyclophosphamide, doxorubicin, and vincristine followed by surgery.
  • 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 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.

Interventional
Phase 2
Primary Purpose: Treatment
Neuroblastoma
  • Drug: carboplatin
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: etoposide
  • Drug: vincristine sulfate
  • Procedure: conventional surgery
Not Provided
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.
 
Completed
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February 2011
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DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed newly diagnosed stage II or III neuroblastoma or ganglioneuroblastoma

    • Unresectable disease
  • No MYCN amplification (i.e., fewer than 10 copies)
  • No metastases to bone marrow
  • No radiological bone lesions in skeleton

PATIENT CHARACTERISTICS:

Age:

  • Under 12 months at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No evidence of liver disease by ultrasound

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Italy,   Norway,   Portugal,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00025597
CDR0000068977, EURO-INF-NB-STUDY-1999-99.1, EU-20125A
Not Provided
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European Infant Neuroblastoma Study Group - 1999
Not Provided
Study Chair: Herve Rubie, MD Centre Hospitalier Regional de Purpan
National Cancer Institute (NCI)
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP