Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002643
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Ewings Sarcoma or Primitive Neuroectodermal Tumor
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
INTENSIVE THERAPY WITH GROWTH FACTOR SUPPORT FOR PATIENTS WITH EWINGS TUMOR METASTATIC AT DIAGNOSIS A PEDIATRIC ONCOLOGY GROUP PHASE II STUDY
Status:
COMPLETED
Status Verified Date:
2007-03
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:
Phase II trial to study the effectiveness of combination chemotherapy in treating patients with newly diagnosed metastatic Ewings sarcoma or primitive neuroectodermal tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
Detailed Description:
OBJECTIVES
I Evaluate the response rate and duration of response of patients with newly diagnosed metastatic Ewings sarcoma or primitive neuroectodermal tumor treated with maximally intensified VAdrC vincristine doxorubicin cyclophosphamide alternating with IE ifosfamide etoposide
II Evaluate the response to new agents first topotecan then topotecan with cyclophosphamide utilized in an upfront treatment window
III Assess the role of surgery with regard to local control of primary and metastatic sites and disease course
IV Evaluate whether individual variability in ifosfamide and cyclophosphamide metabolism correlates with toxicity andor response
V Evaluate the rise in the absolute neutrophil count following one dose of filgrastim G-CSF given immediately prior to a chemotherapy course as an indicator of bone marrow reserve and subsequent myelosuppression
VI Determine if amifostine provides significant chemo-radio protection particularly against the cumulative toxicities of this intensive therapy
OUTLINE This is a partially randomized multicenter study
Patients are treated on the investigational window first or proceed to induction therapy immediately if aggressive treatment is necessary
INVESTIGATIONAL WINDOW Patients receive cyclophosphamide IV and topotecan IV over 30 minutes on days 1-5 Filgrastim G-CSF is administered subcutaneously SQ beginning day 6 until blood cell counts recover Treatment is repeated at week 3
INDUCTION THERAPY Patients over 12 months old are randomized to receive amifostine or not Patients receive etoposide IV over 45 minutes and ifosfamide IV over 2 hours on days 1-5 Amifostine IV over 15 minutes is also administered prior to ifosfamide Patients receive G-CSF SQ or IV over 2 hours beginning on day 6 This course of treatment is administered on weeks 6 12 and 18 Patients receive the VAdrC chemotherapy regimen on weeks 9 and 15 This regimen consists of vincristine IV and amifostine IV over 15 minutes on days 1 8 and 15 cyclophosphamide IV over 30 minutes and doxorubicin IV over 48 hours on days 1 and 2 and G-CSF beginning on day 3 The VAdrC regimen is continued during local therapy on weeks 21-29 and 39-47 except the day 15 dose of vincristine is omitted cyclophosphamide is administered on day 1 only on weeks 21 24 27 39 42 and 45 and doxorubicin is replaced with etoposide IV over 60 minutes on days 1-3 on weeks 24 28 42 and 45 Local therapy begins after 21 weeks of chemotherapy Patients who respond to chemotherapy and have resectable disease undergo a complete resection with negative margins Patients with unresectable disease or bulky lesions undergo radiotherapy Some patients may undergo both surgery and radiotherapy Local therapy of metastases is delayed until after week 39 Patients are followed every 3 months for 1 year every 6 months for 2 years then annually thereafter
I Evaluate the response rate and duration of response of patients with newly diagnosed metastatic Ewings sarcoma or primitive neuroectodermal tumor treated with maximally intensified VAdrC vincristine doxorubicin cyclophosphamide alternating with IE ifosfamide etoposide
II Evaluate the response to new agents first topotecan then topotecan with cyclophosphamide utilized in an upfront treatment window
III Assess the role of surgery with regard to local control of primary and metastatic sites and disease course
IV Evaluate whether individual variability in ifosfamide and cyclophosphamide metabolism correlates with toxicity andor response
V Evaluate the rise in the absolute neutrophil count following one dose of filgrastim G-CSF given immediately prior to a chemotherapy course as an indicator of bone marrow reserve and subsequent myelosuppression
VI Determine if amifostine provides significant chemo-radio protection particularly against the cumulative toxicities of this intensive therapy
OUTLINE This is a partially randomized multicenter study
Patients are treated on the investigational window first or proceed to induction therapy immediately if aggressive treatment is necessary
INVESTIGATIONAL WINDOW Patients receive cyclophosphamide IV and topotecan IV over 30 minutes on days 1-5 Filgrastim G-CSF is administered subcutaneously SQ beginning day 6 until blood cell counts recover Treatment is repeated at week 3
INDUCTION THERAPY Patients over 12 months old are randomized to receive amifostine or not Patients receive etoposide IV over 45 minutes and ifosfamide IV over 2 hours on days 1-5 Amifostine IV over 15 minutes is also administered prior to ifosfamide Patients receive G-CSF SQ or IV over 2 hours beginning on day 6 This course of treatment is administered on weeks 6 12 and 18 Patients receive the VAdrC chemotherapy regimen on weeks 9 and 15 This regimen consists of vincristine IV and amifostine IV over 15 minutes on days 1 8 and 15 cyclophosphamide IV over 30 minutes and doxorubicin IV over 48 hours on days 1 and 2 and G-CSF beginning on day 3 The VAdrC regimen is continued during local therapy on weeks 21-29 and 39-47 except the day 15 dose of vincristine is omitted cyclophosphamide is administered on day 1 only on weeks 21 24 27 39 42 and 45 and doxorubicin is replaced with etoposide IV over 60 minutes on days 1-3 on weeks 24 28 42 and 45 Local therapy begins after 21 weeks of chemotherapy Patients who respond to chemotherapy and have resectable disease undergo a complete resection with negative margins Patients with unresectable disease or bulky lesions undergo radiotherapy Some patients may undergo both surgery and radiotherapy Local therapy of metastases is delayed until after week 39 Patients are followed every 3 months for 1 year every 6 months for 2 years then annually thereafter
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 |
|---|---|---|---|
| POG-9457 | None | None | None |
| CCG-P9457 | None | None | None |
| CDR0000064137 | REGISTRY | PDQ Physician Data Query | None |