Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025610
First received: October 11, 2001
Last updated: September 16, 2013
Last verified: November 2001
  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 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.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); 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 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.

  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 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
  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: NCT00025610

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
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Sponsors and Collaborators
European Infant Neuroblastoma Study Group - 1999
Investigators
Study Chair: Mary P. Gerrard, MBChB, FRCP, FRCPCH Children's Hospital - Sheffield
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025610     History of Changes
Other Study ID Numbers: CDR0000068979, EURO-INF-NB-STUDY-1999-99.2, EU-20125B
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
stage 4S 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
Doxorubicin
Etoposide
Vincristine
Carboplatin
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
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on July 20, 2014