drugset / Trial / NCT00410631

Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

NCT00410631

RandomizedOpen-labelTreatment

Summary

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.

Timeline

Start
2004-10
Primary completion
2010-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravenous
Subject Cisplatin Other / unclassified Intravenous
Subject Cyclophosphamide Other / unclassified Oral
Subject Dacarbazine Small molecule Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Etoposide Small molecule Intravenous
Subject Ifosfamide Small molecule Intravenous
Subject Isotretinoin Other / unclassified Oral
Subject Melphalan Small molecule Intravenous
Subject Topotecan Small molecule Intravenous
Subject Vincristine Small molecule Intravenous
Subject Vindesine Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous

Indications