Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002466
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors Ewings Sarcoma Wilms Tumor or Bone Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Cyclophosphamide Doxorubicin Vincristine Etoposide and Ifosfamide Followed by Resection and Radiotherapy in Patients With Peripheral Primitive Neuroectodermal Tumors or Ewings Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors Ewings sarcoma Wilms tumor or bone cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors Ewings sarcoma Wilms tumor or bone cancer
Detailed Description:
OBJECTIVES I Determine the response rate and event-free survival of patients with peripheral primitive neuroectodermal tumors or Ewings sarcoma treated with cyclophosphamide doxorubicin vincristine etoposide and ifosfamide followed by surgery if feasible and radiotherapy II Determine the response to a uniform treatment regimen in order to clarify whether these disease categories each have a different prognosis
OUTLINE Patients are stratified according to disease category primitive neuroectodermal tumor vs Ewings sarcoma Patients receive treatment on regimen A as outlined below during courses 1-3 and 6 and regimen B as outlined below during courses 4 5 and 7 in the absence of disease progression or unacceptable toxicity Each course lasts 3-4 weeks Patients without metastatic disease after completion of course 3 undergo complete tumor resection if feasible Patients achieving complete response with or without microscopic residual disease after completion of course 7 undergo radiotherapy twice daily 5 days a week for 3 weeks Patients with gross residual disease after completion of course 7 undergo radiotherapy twice daily 5 days a week for 36 weeks Regimens A and B are defined below Regimen A Patients receive cyclophosphamide IV over 6 hours on days 1 and 2 doxorubicin IV continuously and vincristine IV continuously on days 1-3 and vincristine IV on day 9 Regimen B Patients receive etoposide IV over 1 hour followed immediately by ifosfamide IV over 1 hour on days 1-5 Patients are followed monthly for 18 months and then every 6 months for 18 months
PROJECTED ACCRUAL A maximum of 50 patients 25 per stratum will be accrued for this study within 5 years
OUTLINE Patients are stratified according to disease category primitive neuroectodermal tumor vs Ewings sarcoma Patients receive treatment on regimen A as outlined below during courses 1-3 and 6 and regimen B as outlined below during courses 4 5 and 7 in the absence of disease progression or unacceptable toxicity Each course lasts 3-4 weeks Patients without metastatic disease after completion of course 3 undergo complete tumor resection if feasible Patients achieving complete response with or without microscopic residual disease after completion of course 7 undergo radiotherapy twice daily 5 days a week for 3 weeks Patients with gross residual disease after completion of course 7 undergo radiotherapy twice daily 5 days a week for 36 weeks Regimens A and B are defined below Regimen A Patients receive cyclophosphamide IV over 6 hours on days 1 and 2 doxorubicin IV continuously and vincristine IV continuously on days 1-3 and vincristine IV on day 9 Regimen B Patients receive etoposide IV over 1 hour followed immediately by ifosfamide IV over 1 hour on days 1-5 Patients are followed monthly for 18 months and then every 6 months for 18 months
PROJECTED ACCRUAL A maximum of 50 patients 25 per stratum will be accrued for this study within 5 years
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 |
|---|---|---|---|
| NCI-V90-0126 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000076464 | REGISTRY | None | None |
| NYU-97-6 | None | None | None |