Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma Who Are Undergoing Surgery With or Without Autologous Bone Marrow or Peripheral Stem Cell Transplant

NCT00417053 | Unknown Phase 3

• 3 other identifiers: CCLG-NB-1999-03CDR0000454507EU-20597
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known which combination chemotherapy regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed neuroblastoma. PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, works in treating infants with newly diagnosed neuroblastoma.

Conditions

Neuroblastoma

Keywords

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

Interventions

filgrastim BIOLOGICAL

busulfan DRUG

carboplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide phosphate DRUG

melphalan DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

conventional surgery PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed neuroblastoma or ganglioblastoma * Newly diagnosed disease * MYCN status known * Patients are assigned to different study treatment regimens\* according to the following disease criteria: * Regimen NB 99.1 * Localized unresectable tumor * If open surgery is considered too hazardous due to the site of the tumor or condition of the infant, then cytological confirmation is allowed, provided adequate material is obtained for study procedures * No MYCN amplification (i.e., \< 10 copies) * No metastatic deposits in the bone marrow * No MIBG or technetium uptake or radiological bone lesions in the skeleton * No liver disease by ultrasound * Regimen NB 99.2 * Stage 4 or 4S with metastases confined to the skin, marrow, nodes, or liver * No bone involvement by radiographs * No pleural or lung involvement * No CNS involvement * No MYCN amplification (i.e., \< 10 copies) * Regimen NB 99.3 * Stage 4 disease, metastases must meet ≥ 1 of the following criteria: * Skeletal bone metastases by plain x-ray or CT scan * Pleural or lung metastases * CNS involvement * No MYCN amplification (i.e., \< 10 copies) * Regimen NB 99.4 * Stage 2-4 disease * MYCN amplification (i.e., ≥ 10 copies) NOTE: \*Patients with stage 1 or resectable stage 2 disease with no MYCN amplification ( i.e., \< 10 copies) are not eligible for a study treatment regimen but may be enrolled on the study for observation only PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * No prior therapy

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

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; Busulfan; Carboplatin; Cyclophosphamide; Doxorubicin; etoposide phosphate; Melphalan; Vincristine; Peripheral Blood Stem Cell Transplantation; Radiotherapy

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; 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

• Mary P. Gerrard, MBChB, FRCP, FRCPCH

  Children's Hospital - Sheffield

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Last Updated: August 2, 2013

Record last verified: 2006-12