Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma - Full Text View

Sponsor:	University Hospitals, Leicester
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030719

Purpose

RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma.

Condition	Intervention	Phase
Neuroblastoma	Biological: filgrastim Biological: monoclonal antibody Ch14.18 Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: isotretinoin Drug: melphalan Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	High Risk Neuroblastoma Study 1 Of Siop-Europe

Resource links provided by NLM:

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

Primary Outcome Measures:

Event-free survival at 3 years [ Designated as safety issue: No ]
Mean number of febrile events during induction [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate assessed by the International Neuroblastoma Response Criteria after 4 and 8 induction chemotherapy courses [ Designated as safety issue: No ]
Event-free survival at 5 years [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Biological factors (i.e., MycNM amplification, 1p deletion, ploidy, 17 q+, CD44, and Trk-A) [ Designated as safety issue: No ]
Serum concentrations of lactic dehydrogenase, ferritin, neurone specific enolase [ Designated as safety issue: No ]
Urinary catecholamines at diagnosis [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	December 2001

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Eligibility

Ages Eligible for Study:	1 Year to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of neuroblastoma according to International Neuroblastoma Staging System
- Stage 2 or 3 with MycN amplification
- Stage 4
Tumor material available for determination of biological prognostic factors

PATIENT CHARACTERISTICS:

Age:

1 to 20 at diagnosis

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin less than 3 times normal
ALT less than 3 times normal

Renal:

Creatinine less than 1.5 mg/mL
Creatinine clearance and/or glomerular filtration rate at least 60 mL/min

Cardiovascular:

Shortening fraction at least 28% OR
Ejection fraction at least 55%
No clinical congestive heart failure

Pulmonary:

Chest x-ray normal
Oxygen saturation normal

Other:

HIV negative
No Brock grade 2 or greater
No uncontrolled infections requiring IV antivirals, antibiotics, or antifungals
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No more than 1 prior chemotherapy regimen for localized unresectable disease
No concurrent anthracyclines
No other concurrent chemotherapy

Endocrine:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

No other concurrent investigational therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030719

Show 32 Study Locations

Sponsors and Collaborators

University Hospitals, Leicester

Investigators

Study Chair:

Ruth Ladenstein, MD

St. Anna Kinderkrebsforschung

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Ladenstein R, Valteau-Couanet D, Brock P, Yaniv I, Castel V, Laureys G, Malis J, Papadakis V, Lacerda A, Ruud E, Kogner P, Garami M, Balwierz W, Schroeder H, Beck-Popovic M, Schreier G, Machin D, Pötschger U, Pearson A. Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study. J Clin Oncol. 2010 Jul 20;28(21):3516-24. Epub 2010 Jun 21.

ClinicalTrials.gov Identifier:	NCT00030719 History of Changes
Other Study ID Numbers:	CDR0000069191, SIOP-EUROPE-HR-NBL-1, ESIOP, EU-20148
Study First Received:	February 14, 2002
Last Updated:	December 6, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

regional neuroblastoma
disseminated neuroblastoma
stage 4S neuroblastoma
localized unresectable 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
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Busulfan
Cyclophosphamide

Melphalan
Lenograstim
Etoposide
Vincristine
Carboplatin
Isotretinoin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012