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

Sponsor

European Infant Neuroblastoma Study Group - 1999 (Other)

Overall Status

Completed

CT.gov ID

NCT00025597

Collaborator

(none)

Locations

139.1

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

European Infant Neuroblastoma Study - Unresectable Tumors (MYCN Not Amplified)

Study Start Date :

Jul 1, 1999

Actual Study Completion Date :

Feb 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Anna Children's Hospital	Vienna		Austria	A-1090
2	Universitair Ziekenhuis Gent	Ghent		Belgium	B-9000
3	Rigshospitalet	Copenhagen		Denmark	2100
4	Centre Hospitalier Regional de Purpan	Toulouse		France	31026
5	Istituto Giannina Gaslini	Genoa		Italy	16148
6	Rikshospitalet University Hospital	Oslo		Norway	0027
7	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.	Lisboa		Portugal	1099-023 Codex
8	Hospital Universitario LA FE	Valencia		Spain	46009
9	Ostra Sjukhuset	Gothenburg		Sweden	41685
10	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	CH-1011
11	Bristol Royal Hospital for Children	Bristol	England	United Kingdom	BS2 8BJ