Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00025649|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
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 or disease||Intervention/treatment||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 2|
- Determine the survival of infants with newly diagnosed stage II, III, IV, or IVS neuroblastoma with MYCN amplification treated with etoposide, carboplatin, cyclophosphamide, doxorubicin, and vincristine followed by surgery and busulfan and melphalan with autologous peripheral blood stem cell or bone marrow transplantation.
- Determine whether there are prognostic criteria that could be used in future therapeutic stratification of these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors|
|Study Start Date :||July 1999|
|Study Completion Date :||March 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025649
|St. Anna Children's Hospital|
|Vienna, Austria, A-1090|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Copenhagen, Denmark, 2100|
|Centre Hospitalier Regional de Purpan|
|Toulouse, France, 31026|
|Istituto Giannina Gaslini|
|Genoa, Italy, 16148|
|Rikshospitalet University Hospital|
|Oslo, Norway, 0027|
|Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.|
|Lisboa, Portugal, 1099-023 Codex|
|Hospital Universitario LA FE|
|Valencia, Spain, 46009|
|Gothenburg, Sweden, 41685|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Bristol Royal Hospital for Children|
|Bristol, England, United Kingdom, BS2 8BJ|
|Study Chair:||Adela Canete, MD, PhD||Hospital Universitario La Fe|