Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma

NCT00002802 | Completed Phase 3

• 3 other identifiers: CDR0000064902GER-NB90EU-96004
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is most effective in treating patients with different stages of and risk factors for neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of therapy based on stage of disease and risk assessment in treating children with neuroblastoma.

Conditions

Neuroblastoma

Keywords

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

Interventions

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

dacarbazine DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

melphalan DRUG

mesna DRUG

vincristine sulfate DRUG

vindesine DRUG

autologous bone marrow transplantation PROCEDURE

conventional surgery PROCEDURE

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET electron therapy RADIATION

low-LET photon therapy RADIATION

radioisotope therapy RADIATION

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Neuroblastoma with diagnosis based on one of the following: Histologic confirmation Cytologic confirmation in bone marrow and elevated catecholamine metabolites Typical tumor appearance on CT, MRI, or ultrasound and: Unequivocal MIBG uptake in tumor Elevated catecholamines in serum or urine No primitive neuroectodermal tumor or primary intracerebral neuroblastoma Such patients referred to protocol GER-HIT90 PATIENT CHARACTERISTICS: Age: Under 21 Other: No serious cerebral trouble No severe concomitant disease, e.g.: No severe congenital malformation No severe organ function abnormality PRIOR CONCURRENT THERAPY: No prior cytostatic therapy (e.g., for Wilms' tumor) No concurrent therapy

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

University of Cologne

Frechen, DOH-5-0226, Germany

Location

Related Publications (7)

• Krams M, Hero B, Berthold F, Parwaresch R, Harms D, Rudolph P. Proliferation marker KI-S5 discriminates between favorable and adverse prognosis in advanced stages of neuroblastoma with and without MYCN amplification. Cancer. 2002 Feb 1;94(3):854-61.

  PMID: 11857322 BACKGROUND

• Simon T, Hero B, Dupuis W, Selle B, Berthold F. The incidence of hearing impairment after successful treatment of neuroblastoma. Klin Padiatr. 2002 Jul-Aug;214(4):149-52. doi: 10.1055/s-2002-33179.

  PMID: 12165893 BACKGROUND

• Berthold F, Hero B, Kremens B, Handgretinger R, Henze G, Schilling FH, Schrappe M, Simon T, Spix C. Long-term results and risk profiles of patients in five consecutive trials (1979-1997) with stage 4 neuroblastoma over 1 year of age. Cancer Lett. 2003 Jul 18;197(1-2):11-7. doi: 10.1016/s0304-3835(03)00076-4.

  PMID: 12880954 BACKGROUND

• von Schweinitz D, Hero B, Berthold F. The impact of surgical radicality on outcome in childhood neuroblastoma. Eur J Pediatr Surg. 2002 Dec;12(6):402-9. doi: 10.1055/s-2002-36952.

  PMID: 12548494 BACKGROUND

• Simon T, Hero B, Hunneman DH, Berthold F. Tumour markers are poor predictors for relapse or progression in neuroblastoma. Eur J Cancer. 2003 Sep;39(13):1899-903. doi: 10.1016/s0959-8049(03)00376-9.

  PMID: 12932669 RESULT

• Haberle B, Hero B, Berthold F, von Schweinitz D. Characteristics and outcome of thoracic neuroblastoma. Eur J Pediatr Surg. 2002 Jun;12(3):145-50. doi: 10.1055/s-2002-32721.

  PMID: 12101494 RESULT

• Hero B, Hunneman DH, Gahr M, Berthold F. Evaluation of catecholamine metabolites, mIBG scan, and bone marrow cytology as response markers in stage 4 neuroblastoma. Med Pediatr Oncol. 2001 Jan;36(1):220-3. doi: 10.1002/1096-911X(20010101)36:13.0.CO;2-6.

  PMID: 11464889 RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Ifosfamide; Melphalan; Mesna; Vincristine; Vindesine

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)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Frank Berthold, MD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 12, 2004
• Study Start: July 1, 1990
• Study Completion: September 1, 2003
• Last Updated: December 19, 2013

Record last verified: 2007-05

Locations

DE (1)