Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma

European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN Not Amplified

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00025610

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-07-31

Completion date

2009-03-31

Last updated

2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

disseminated neuroblastoma, stage 4S neuroblastoma

Brief 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 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.

Detailed description

OBJECTIVES: * 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. * 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 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. PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study within 4 years.

Interventions

DRUGcarboplatin

DRUGcyclophosphamide

DRUGdoxorubicin hydrochloride

DRUGetoposide

DRUGvincristine sulfate

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Years

Healthy volunteers

Inclusion 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) 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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026