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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025623
First received: October 11, 2001
Last updated: September 16, 2013
Last verified: December 2002
  Purpose

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.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1999
Study Completion Date: March 2009
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025623

Locations
Austria
St. Anna Children's Hospital
Vienna, Austria, A-1090
Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
France
Centre Hospitalier Regional de Purpan
Toulouse, France, 31026
Italy
Istituto Giannina Gaslini
Genoa, Italy, 16148
Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
Lisboa, Portugal, 1099-023 Codex
Spain
Hospital Universitario LA FE
Valencia, Spain, 46009
Sweden
Ostra Sjukhuset
Gothenburg, Sweden, 41685
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom, BS2 8BJ
Sponsors and Collaborators
European Infant Neuroblastoma Study Group - 1999
Investigators
Study Chair: Bruno De Bernardi, MD Istituto Giannina Gaslini
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025623     History of Changes
Other Study ID Numbers: CDR0000068980, EURO-INF-NB-STUDY-1999-99.3, EU-20125C
Study First Received: October 11, 2001
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 22, 2014