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Sponsored by: |
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00410631 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether observation is more effective than combination chemotherapy, radiation therapy, and/or autologous stem cell transplant in treating neuroblastoma.
PURPOSE: This randomized phase III and phase IV trial is studying observation, combination chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well they work in treating young patients with neuroblastoma.
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: ifosfamide Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Drug: vindesine Procedure: autologous hematopoietic stem cell transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: iobenguane I 131 Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma |
Estimated Enrollment: | 642 |
Study Start Date: | October 2004 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, historically controlled, randomized, open-label, multicenter study. Patients are stratified according to disease risk (low-risk vs medium-risk vs high-risk).
Medium-risk group: Patients receive induction therapy followed by maintenance therapy and consolidation therapy.
Patients then proceed to maintenance therapy. NOTE: *Patients under 6 months of age receive up to 4 courses of N4 chemotherapy (as in the low-risk group) instead of N5/N6 chemotherapy until they reach 6 months of age.
Patients with active residual tumor after induction chemotherapy undergo external-beam radiotherapy (EBRT) for up to 25 fractions concurrently with maintenance chemotherapy. Secondary surgery for resection of the primary tumor is attempted after course 4 or 6 of the induction therapy and before EBRT.
Consolidation therapy: Beginning 21 days after completion of maintenance therapy, patients receive oral isotretinoin 2-3 times daily on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity. Patients then receive 3 additional courses after 3-months of rest.
Induction therapy: Patients 1 year of age and over are randomized to 1 of 2 treatment arms. Patients under 1 year of age do not undergo randomization; instead they are assigned to arm I.
In both arms, patients with active residual primary tumor after 6 courses of induction therapy undergo iodine I 131 metaiodobenzylguanidine (MIBG)** radiotherapy (before ASCT). Patients also undergo EBRT for up to 25 fractions after ASCT. Secondary surgery for resection of the primary tumor is attempted after course 4 or 6 of induction therapy and before radiotherapy.
NOTE: *Patients under 6 months of age receive up to 4 courses of N4 chemotherapy (as in the low-risk group) instead of N5/N6 chemotherapy until they reach 6 months of age.
NOTE: **Patients with MIBG-negative disease undergo EBRT only.
NOTE: *Isotretinoin is discontinued during EBRT and restarted 1 week after completion of EBRT.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma by histology using tumor tissue or as evidenced by the presence of distinct neuroblastoma cells in the bone marrow AND elevated catecholamine metabolites (i.e., homovanillic acid [HVA] and vanillylmandelic acid [VMA]) in blood or urine
Meets criteria for 1 of the following risk groups:
Low-risk group
No MYCN amplification AND meets 1 of the following criteria:
Medium-risk group
No MYCN amplification AND meets 1 of the following criteria:
Stage 3 disease with chromosome 1p deletion or imbalance
High-risk group, meeting 1 of the following criteria:
Any stage disease with MYCN amplification
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Frank Berthold, MD | Children's Hospital |
Study ID Numbers: | CDR0000517312, GPOH-NB2004, EU-20661 |
Study First Received: | December 11, 2006 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00410631 History of Changes |
Health Authority: | Unspecified |
localized resectable neuroblastoma localized unresectable neuroblastoma regional neuroblastoma |
stage 4S neuroblastoma disseminated neuroblastoma recurrent neuroblastoma |
Melphalan Neuroectodermal Tumors, Primitive Dacarbazine Immunologic Factors Vindesine Cyclophosphamide Etoposide phosphate Neuroblastoma Anti-Bacterial Agents Cisplatin 3-Iodobenzylguanidine Neoplasms, Germ Cell and Embryonal Isotretinoin Neuroepithelioma Alkylating Agents |
Etoposide Vincristine Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Recurrence Neuroectodermal Tumors Ifosfamide Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Topotecan Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral |
Dacarbazine Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Etoposide phosphate Neuroblastoma 3-Iodobenzylguanidine Therapeutic Uses Neoplasms, Germ Cell and Embryonal Isotretinoin |
Dermatologic Agents Alkylating Agents Etoposide Neoplasms by Histologic Type Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Ifosfamide Neoplasms |