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| Sponsors and Collaborators: |
Societe Internationale d'Oncologie Pediatrique Children's Cancer and Leukaemia Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025428 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours on days 1-3 (courses 1 and 3). Patients receive cyclophosphamide IV over 1 hour on days 1-5 (or orally on days 2 and 3), doxorubicin IV over 6 hours on days 4-5, and vincristine IV on days 1 and 5 (courses 2 and 4). Treatment repeats every 21 days for 4 courses.
Patients then undergo surgical resection followed by 2 additional courses of chemotherapy.
Patients are followed at months 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, and 60.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of localized unresectable neuroblastoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Austria | |
| St. Anna Children's Hospital | |
| Vienna, Austria, A-1090 | |
| Belgium | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| Denmark | |
| Odense University Hospital | |
| Odense, Denmark, DK-5000 | |
| France | |
| Centre Hospitalier Regional de Purpan | |
| Toulouse, France, 31026 | |
| Germany | |
| Children's Hospital | |
| Cologne, Germany, D-50924 | |
| 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, England | |
| Southampton University Hospital NHS Trust | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Study Chair: | Janice A. Kohler, MD, FRCP | Southampton General Hospital |
| Study Chair: | Janice A. Kohler, MD, FRCP | Southampton General Hospital |
More Information
| Study ID Numbers: | CDR0000068960, SIOP-NB-2009, CCLG-NB-2000-09, EU-20107 |
| Study First Received: | October 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00025428 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized unresectable neuroblastoma |
|
Neuroectodermal Tumors, Primitive Immunologic Factors Adjuvants, Immunologic Vincristine Antimitotic Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Etoposide phosphate Neuroblastoma Doxorubicin Anti-Bacterial Agents |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
|
Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neuroblastoma Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Mitosis Modulators Vincristine |
Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
