Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072280
Status:
TERMINATED
Last Update Posted:
2014-09-30
First Post:
2003-11-04
Brief Title:
Surgery andor Chemotherapy in Treating Children With Infantile Congenital or Childhood Fibrosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Phase II Study for Children With Infantile Fibrosarcoma
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to poor accrual
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 work in different ways to stop tumor cells from dividing so they stop growing or die Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed Giving combination chemotherapy after surgery may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well surgery andor combination chemotherapy work in treating children with fibrosarcoma
PURPOSE This phase II trial is studying how well surgery andor combination chemotherapy work in treating children with fibrosarcoma
Detailed Description:
OBJECTIVES
Primary
Determine the event-free and relapse-free survival of children with initially unresectable congenital infantile or childhood fibrosarcoma treated with neoadjuvant chemotherapy comprising vincristine dactinomycin and cyclophosphamide VAC before definitive local control
Secondary
Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by observation after local control with positive microscopic margins
Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by additional chemotherapy comprising etoposide and ifosfamide after local control with gross positive margins
Determine the event-free and relapse-free survival of patients treated with surgery alone
OUTLINE This is a pilot multicenter study Patients begin treatment according to lesion resectability
Patients with resectable lesions proceed to surgery
Surgery Patients undergo resection of disease lesions Patients with clear or microscopically positive margins undergo observation only Patients with grossly positive margins undergo re-resection if feasible Patients with grossly positive margins after re-resection or for whom re-resection is not feasible receive chemotherapy comprising vincristine dactinomycin and cyclophosphamide VAC
Patients with unresectable lesions receive VAC chemotherapy
VAC chemotherapy Patients receive vincristine intravenously IV on days 1 8 and 15 and dactinomycin IV and cyclophosphamide IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression after 2-4 courses of VAC chemotherapy proceed to chemotherapy comprising etoposide and ifosfamide IE
Patients with stable disease after 4 courses of VAC chemotherapy proceed to IE chemotherapy
Patients with a partial response PR and unresectable lesions after 4 courses of VAC chemotherapy receive 2 additional courses of VAC and are then re-evaluated Patients proceed to surgery if they continue to have a PR or achieve a complete response CR and lesions are now resectable
Patients with a CR or PR and resectable lesions after 4 courses of VAC chemotherapy proceed to surgery
Patients with stable disease progressive disease or a PR and unresectable lesions after 6 courses of VAC proceed to IE chemotherapy
IE chemotherapy Patients receive etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with a CR or PR and resectable lesions after 2-4 courses of IE chemotherapy proceed to surgery
All patients are followed every 3 months for 6 months every 6 months for 1 year and then as clinically indicated
PROJECTED ACCRUAL A total of 60-70 patients will be accrued for this study within 8 years
Primary
Determine the event-free and relapse-free survival of children with initially unresectable congenital infantile or childhood fibrosarcoma treated with neoadjuvant chemotherapy comprising vincristine dactinomycin and cyclophosphamide VAC before definitive local control
Secondary
Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by observation after local control with positive microscopic margins
Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by additional chemotherapy comprising etoposide and ifosfamide after local control with gross positive margins
Determine the event-free and relapse-free survival of patients treated with surgery alone
OUTLINE This is a pilot multicenter study Patients begin treatment according to lesion resectability
Patients with resectable lesions proceed to surgery
Surgery Patients undergo resection of disease lesions Patients with clear or microscopically positive margins undergo observation only Patients with grossly positive margins undergo re-resection if feasible Patients with grossly positive margins after re-resection or for whom re-resection is not feasible receive chemotherapy comprising vincristine dactinomycin and cyclophosphamide VAC
Patients with unresectable lesions receive VAC chemotherapy
VAC chemotherapy Patients receive vincristine intravenously IV on days 1 8 and 15 and dactinomycin IV and cyclophosphamide IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression after 2-4 courses of VAC chemotherapy proceed to chemotherapy comprising etoposide and ifosfamide IE
Patients with stable disease after 4 courses of VAC chemotherapy proceed to IE chemotherapy
Patients with a partial response PR and unresectable lesions after 4 courses of VAC chemotherapy receive 2 additional courses of VAC and are then re-evaluated Patients proceed to surgery if they continue to have a PR or achieve a complete response CR and lesions are now resectable
Patients with a CR or PR and resectable lesions after 4 courses of VAC chemotherapy proceed to surgery
Patients with stable disease progressive disease or a PR and unresectable lesions after 6 courses of VAC proceed to IE chemotherapy
IE chemotherapy Patients receive etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with a CR or PR and resectable lesions after 2-4 courses of IE chemotherapy proceed to surgery
All patients are followed every 3 months for 6 months every 6 months for 1 year and then as clinically indicated
PROJECTED ACCRUAL A total of 60-70 patients will be accrued for this study within 8 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 |
|---|---|---|---|
| COG-ARST03P1 | OTHER | Childrens Oncology Group | None |
| CDR0000339565 | OTHER | None | None |
| NCI-2012-02561 | OTHER | None | None |