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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: | NCT00526318 |
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.
PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.
Condition | Intervention |
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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 Radiation: iodine I 131 metaiodobenzylguanidine Radiation: radiation therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR) |
Estimated Enrollment: | 360 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma according to any of the following criteria:
High-risk disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Frank Berthold, MD | Children's Hospital |
Study ID Numbers: | CDR0000564820, GPOH-NB2004-HR, UNI-KOELN-161 |
Study First Received: | September 5, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00526318 History of Changes |
Health Authority: | Unspecified |
localized resectable neuroblastoma localized unresectable neuroblastoma regional neuroblastoma stage 4S neuroblastoma disseminated 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 Iodine Neuroepithelioma |
Alkylating Agents Etoposide Vincristine Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin 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 |