Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Under 12 months at diagnosis	Other	EURO-INF-NB-STUDY-1999-99.2 EU-20125B, NCT00025610

Objectives

1. 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.
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 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)

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:

• Not specified

Renal:

• Not specified

Expected Enrollment

A total of 130 patients will be accrued for this study within 4 years.

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.

De Bernardi B, Gerrard M, Boni L, et al.: Excellent outcome with reduced treatment for infants with disseminated neuroblastoma without MYCN gene amplification. J Clin Oncol 27 (7): 1034-40, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Infant Neuroblastoma Study 1999 Group

Mary Gerrard, MBChB, FRCP, FRCPCH, Protocol chair		Ph: 44-114-271-7366 Email: mary.gerrard@sch.nhs.uk

Registry Information
Official Title		European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN not Amplified
Trial Start Date		1999-07-01
Registered in ClinicalTrials.gov		NCT00025610
Date Submitted to PDQ		2001-08-28
Information Last Verified		2001-11-01

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