Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001335
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
New Therapeutic Strategies for Patients With Ewings Sarcoma Family of Tumors High Risk Rhabdomyosarcoma and Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
New Therapeutic Strategies for Patients With Ewings Sarcoma Family of Tumors High Risk Rhabdomyosarcoma and Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prognosis for patients with metastatic Ewings 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
Detailed Description:
The prognosis for patients with metastatic Ewings 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-C-0125 | None | None | None |