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

Neuroblastoma Clinical Trial

Official title:

European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025623
• Other study ID #: CDR0000068980
• Secondary ID: EURO-INF-NB-STUD
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2001
• Last updated: September 16, 2013
• Start date: July 1999
• Est. completion date: March 2009

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them 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.

Description:

OBJECTIVES:

• 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.

• 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 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.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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)

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• carboplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• vincristine sulfate

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Austria	St. Anna Children's Hospital	Vienna
Belgium	Universitair Ziekenhuis Gent	Ghent
Denmark	Rigshospitalet	Copenhagen
France	Centre Hospitalier Regional de Purpan	Toulouse
Italy	Istituto Giannina Gaslini	Genoa
Norway	Rikshospitalet University Hospital	Oslo
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.	Lisboa
Spain	Hospital Universitario LA FE	Valencia
Sweden	Ostra Sjukhuset	Gothenburg
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Bristol Royal Hospital for Children	Bristol	England

Sponsors (1)

Lead Sponsor	Collaborator
European Infant Neuroblastoma Study Group - 1999

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Italy,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

De Bernardi B, Gerrard M, Boni L, Rubie H, Cañete A, Di Cataldo A, Castel V, Forjaz de Lacerda A, Ladenstein R, Ruud E, Brichard B, Couturier J, Ellershaw C, Munzer C, Bruzzi P, Michon J, Pearson AD. Excellent outcome with reduced treatment for infants with disseminated neuroblastoma without MYCN gene amplification. J Clin Oncol. 2009 Mar 1;27(7):1034-40. doi: 10.1200/JCO.2008.17.5877. Epub 2009 Jan 26. — View Citation