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Sponsored by: |
European Infant Neuroblastoma Study Group - 1999 |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025623 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified |
Study Start Date: | July 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses.
Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy. Patients with metastatic complete response (CR) undergo surgical resection of primary disease.
Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for 2 courses.
After 2 courses of CADO chemotherapy, patients with metastatic CR undergo surgical resection of primary disease.
Patients with residual disease receive 2 additional courses of CADO chemotherapy. Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study. Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 4 years.
Ages Eligible for Study: | up to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed stage IV neuroblastoma or ganglioneuroblastoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Austria | |
St. Anna Children's Hospital | |
Vienna, Austria, A-1090 | |
Belgium | |
Universitair Ziekenhuis Gent | |
Ghent, Belgium, B-9000 | |
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
France | |
Centre Hospitalier Regional de Purpan | |
Toulouse, France, 31026 | |
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 | |
Bristol Royal Hospital for Children | |
Bristol, England, United Kingdom, BS2 8BJ |
Study Chair: | Bruno De Bernardi, MD | Istituto Giannina Gaslini |
Study ID Numbers: | CDR0000068980, EURO-INF-NB-STUDY-1999-99.3, EU-20125C |
Study First Received: | October 11, 2001 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00025623 History of Changes |
Health Authority: | United States: Federal Government |
disseminated neuroblastoma |
Neuroectodermal Tumors, Primitive Immunologic Factors 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 |