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Clinical Trials (PDQ®)

  • First Published: 10/1/2001
  • Last Modified: 3/14/2011

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Phase II Study of Vincristine and Cyclophosphamide, Etoposide and Carboplatin, and Cyclophosphamide, Doxorubicin, and Vincristine Followed By Surgery in Infants With Newly Diagnosed Stage II or III Unresectable Neuroblastoma Without MYCN Amplification. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedUnder 12 months at diagnosisOtherEURO-INF-NB-STUDY-1999-99.1
EU-20125A, NCT00025597

Objectives

  1. 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.
  2. Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.
  3. Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

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

Expected Enrollment

A total of 100 patients will be accrued for this study within 4 years.

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.

Published Results

Rubie H, De Bernardi B, Gerrard M, et al.: 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 29 (4): 449-55, 2011.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Infant Neuroblastoma Study 1999 Group

Herve Rubie, MD, Protocol chair
Ph: 33-53-455-8611
Email: rubie.h@chu-toulouse.fr

Registry Information
Official Title European Infant Neuroblastoma Study - Unresectable Tumors (MYCN not Amplified)
Trial Start Date 1999-07-01
Registered in ClinicalTrials.gov NCT00025597
Date Submitted to PDQ 2001-08-28
Information Last Verified 2001-11-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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