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

Alternate Title

Combination Chemotherapy Followed by Surgery 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-1999-99.3 EU-20125C, NCT00025623

Objectives

1. 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.
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 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)

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 60 patients will be accrued for this study within 4 years.

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.

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

Bruno De Bernardi, MD, Protocol chair		Ph: 39-10-563-6464 Email: brunodebernardi@ospedale-gaslini.ge.it

Registry Information
Official Title		European Infant Neuroblastoma Study - Stage 4 with Bone, Lung, Pleura or CNS Involvement; MYCN not Amplified
Trial Start Date		1999-07-01
Registered in ClinicalTrials.gov		NCT00025623
Date Submitted to PDQ		2001-08-28
Information Last Verified		2002-12-24

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