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| Sponsors and Collaborators: |
Children's Cancer and Leukaemia Group Societe Francaise Oncologie Pediatrique |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024193 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. Chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation may be an effective treatment for metastatic neuroblastoma.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation in treating patients who have metastatic neuroblastoma.
| Condition | Intervention | Phase |
|
Neuroblastoma |
Drug: busulfan Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: melphalan Drug: vincristine sulfate Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation |
Phase II |
| MedlinePlus related topics: | Cancer Neuroblastoma |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis |
| Study Start Date: | April 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 1 and 2 and doxorubicin IV continuously and vincristine IV continuously over days 1-3 of courses 1, 2, 4, and 6. Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide IV over 2 hours on days 1-3 of induction courses 3, 5, and 7. Patients also receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 5 of courses 3, 5, and 7 and continuing until blood counts recover. Treatment repeats every 21 days.
At the completion of induction chemotherapy, patients undergo surgical resection. Patients in complete remission receive high-dose consolidation chemotherapy comprising oral busulfan every 6 hours on days -7 to -3 and melphalan IV over 2 minutes on day -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0. Patients with n-myc tumor amplification undergo radiotherapy at least 70 days after PBSC transplantation.
Patients are followed every 6 months.
PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic disease demonstrated by at least 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| France | |||||
| Institut Gustave Roussy | |||||
| Villejuif, France, F-94805 | |||||
| Children's Cancer and Leukaemia Group |
| Societe Francaise Oncologie Pediatrique |
| Study Chair: | Janice A. Kohler, MD, FRCP | Southampton General Hospital |
| Study Chair: | D. Valteau-Couanet | Institut Gustave Roussy |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000068899, CCLG-NB-1999-02, SFOP-NB97, EU-20106 |
| First Received: | September 13, 2001 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00024193 |
| Health Authority: | United States: Federal Government |
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