Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma

NCT00025649 | Completed Phase 2

• 3 other identifiers: CDR0000068982EURO-INF-NB-STUDY-1999-99.4EU-20125D
• Study Type: interventional
• Target: N/A
• Locations: 11 countries
• Sites: 11

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma; regional neuroblastoma; disseminated neuroblastoma; stage 4S neuroblastoma; localized unresectable neuroblastoma

Interventions

filgrastim BIOLOGICAL

busulfan DRUG

carboplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

melphalan DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

conventional surgery PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed stage II, III, IV, or IVS neuroblastoma or ganglioneuroblastoma * MYCN amplification (i.e., at least 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Infant Neuroblastoma Study Group - 1999: lead

Study Sites (11)

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31026, France

Location

Istituto Giannina Gaslini

Genoa, 16148, Italy

Location

Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

Lisbon, 1099-023 Codex, Portugal

Location

Hospital Universitario LA FE

Valencia, 46009, Spain

Location

Ostra Sjukhuset

Gothenburg, 41685, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

Location

Related Publications (1)

• Canete A, Gerrard M, Rubie H, Castel V, Di Cataldo A, Munzer C, Ladenstein R, Brichard B, Bermudez JD, Couturier J, de Bernardi B, Pearson AJ, Michon J. Poor survival for infants with MYCN-amplified metastatic neuroblastoma despite intensified treatment: the International Society of Paediatric Oncology European Neuroblastoma Experience. J Clin Oncol. 2009 Mar 1;27(7):1014-9. doi: 10.1200/JCO.2007.14.5839. Epub 2009 Jan 26.

  PMID: 19171715 RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; Busulfan; Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Melphalan; Vincristine; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Coordination Complexes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Adela Canete, MD, PhD

  Hospital Universitario La Fe

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Study Completion: March 1, 2009
• Last Updated: September 17, 2013

Record last verified: 2001-12

Locations

SE (1); CH (1); AU (1); GB (1); DK (1); IT (1); NO (1); FR (1); PT (1); BE (1); ES (1)