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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00025623

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

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, 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.

Detailed 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.

Interventions

DRUGcarboplatin

DRUGcyclophosphamide

DRUGdoxorubicin hydrochloride

DRUGetoposide

DRUGvincristine sulfate

PROCEDUREconventional surgery

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 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

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