New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma
The prognosis for patients with metastatic Ewing's sarcoma family of tumors (ESF),
rhabdomyosarcoma (RMS), and neuroblastoma (NBL) remains dismal, with less than 25% long-term
disease-free survival. Though less grave, the prognosis for cure for other high-risk
patients is approximately 50%. New treatment strategies, including the identification of
highly active new agents, maximizing the dose intensity of the most active standard drugs,
and the development of improved methods of consolidation to eradicate microscopic residual
disease, are clearly needed to improve the outcome of these patients. This protocol will
address these issues by commencing with a Phase II window, for the highest risk patients, to
evaluate a series of promising drugs with novel mechanisms of action. All patients will
then receive 5 cycles of dose-intensive "best standard therapy" with doxorubicin
(adriamycin), vincristine, and cyclophosphamide (VAdriaC). Patients at high risk of relapse
will continue onto a phase I consolidation regimen consisting of three cycles of
dose-escalated Melphalan, Ifosfamide, Mesna, and Etoposide (MIME). Peripheral blood stem
cell transfusions (PBSCT) and recombinant human G-CSF will be used as supportive care
measures to allow maximal dose-escalation of this combination regimen.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
930125
NCT00001335
April 1993
January 2002
Name | Location |
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National Cancer Institute (NCI) | Bethesda, Maryland 20892 |