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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: | NCT00025649 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Biological: filgrastim Drug: busulfan Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: melphalan Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors |
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 then 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.
Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days. Patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not mobilize sufficient cells undergo bone marrow harvest.
Patients eligible for surgery undergo surgical resection. Patients with stage IV disease with less than complete response of metastatic disease after initial chemotherapy are removed from the study.
Beginning within 2 weeks after surgery, patients receive 1 additional course of VP-CARBO chemotherapy followed by
1 additional course of CADO chemotherapy.
After at least 3 weeks, patients receive high-dose chemotherapy comprising busulfan IV over 24 hours on days -7 to -3 and melphalan IV on day -2. PBSC or bone marrow are reinfused on day 0.
At least 2 months after the completion of high-dose chemotherapy and bone marrow or PBSC transplantation, patients undergo radiotherapy to the primary site, according to preoperative imaging studies. Patients are treated with oral tretinoin after megatherapy.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 40 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:
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: | Adela Canete, MD, PhD | Hospital Universitario La Fe |
Study ID Numbers: | CDR0000068982, EURO-INF-NB-STUDY-1999-99.4, EU-20125D |
Study First Received: | October 11, 2001 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00025649 History of Changes |
Health Authority: | United States: Federal Government |
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma localized unresectable neuroblastoma |
Melphalan Neuroectodermal Tumors, Primitive Immunologic Factors Vincristine Antimitotic Agents Carboplatin Cyclophosphamide Immunosuppressive Agents Etoposide phosphate Neuroblastoma Doxorubicin Anti-Bacterial Agents |
Neuroectodermal Tumors Busulfan 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 |