Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025363
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2001-10-11
Brief Title:
Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma Drugs used in chemotherapy work in 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 Compare response rate in children with relapsed or progressive rhabdomyosarcoma undifferentiated sarcoma or ectomesenchymoma treated with 2 different schedules of irinotecan and vincristine in an upfront phase II window
II Determine the progression-free and overall survival of patients treated with multiagent chemotherapy
III Determine the toxic effects of tirapazamine doxorubicin and cyclophosphamide in these patients
IV Determine the toxic effects of irinotecan and vincristine in these patients
V Determine whether conversion of irinotecan to its active metabolite SN-38 predicts tumor response in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to risk status and window therapy eligibility unfavorable risk and eligible vs unfavorable risk and ineligible vs favorable risk
UNFAVORABLE-RISK PATIENTS ELIGIBLE FOR WINDOW THERAPY Patients are stratified according to prior topotecan yes vs no These patients are randomized to 1 of 2 treatment arms
ARM I Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients in both arms with partial response PR or complete response CR receive 5 additional courses of irinotecan and vincristine on the previous schedule In addition patients with PR or CR also receive cyclophosphamidedoxorubicin CD and ifosfamideetoposide IE chemotherapy
CDIE CHEMOTHERAPY Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 7 16 28 37 and 40 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 10 19 22 31 and 43 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients with no response or progressive disease on arm I or II proceed to tirapazaminecyclophosphamidedoxorubicin TCD and ifosfamideetoposide IE chemotherapy
TCDIE CHEMOTHERAPY Patients receive tirapazamine IV over 2 hours cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 7 10 16 25 and 34 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 13 19 22 28 31 and 37
PATIENTS WITH UNFAVORABLE RISK AND INELIGIBLE FOR WINDOW THERAPY Patients receive tirapazamine IV over 2 hours cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 1 4 10 19 and 28 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7 13 16 22 25 and 31 Patients also receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously SC beginning 1 day after each course of chemotherapy and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
PATIENTS WITH FAVORABLE RISK Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 1 4 10 19 and 28 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7 13 16 22 25 and 31 Patients also receive G-CSF or GM-CSF SC beginning 1 day after each course of chemotherapy and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 4 months for 2 years and then annually thereafter
I Compare response rate in children with relapsed or progressive rhabdomyosarcoma undifferentiated sarcoma or ectomesenchymoma treated with 2 different schedules of irinotecan and vincristine in an upfront phase II window
II Determine the progression-free and overall survival of patients treated with multiagent chemotherapy
III Determine the toxic effects of tirapazamine doxorubicin and cyclophosphamide in these patients
IV Determine the toxic effects of irinotecan and vincristine in these patients
V Determine whether conversion of irinotecan to its active metabolite SN-38 predicts tumor response in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to risk status and window therapy eligibility unfavorable risk and eligible vs unfavorable risk and ineligible vs favorable risk
UNFAVORABLE-RISK PATIENTS ELIGIBLE FOR WINDOW THERAPY Patients are stratified according to prior topotecan yes vs no These patients are randomized to 1 of 2 treatment arms
ARM I Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients in both arms with partial response PR or complete response CR receive 5 additional courses of irinotecan and vincristine on the previous schedule In addition patients with PR or CR also receive cyclophosphamidedoxorubicin CD and ifosfamideetoposide IE chemotherapy
CDIE CHEMOTHERAPY Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 7 16 28 37 and 40 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 10 19 22 31 and 43 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients with no response or progressive disease on arm I or II proceed to tirapazaminecyclophosphamidedoxorubicin TCD and ifosfamideetoposide IE chemotherapy
TCDIE CHEMOTHERAPY Patients receive tirapazamine IV over 2 hours cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 7 10 16 25 and 34 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 13 19 22 28 31 and 37
PATIENTS WITH UNFAVORABLE RISK AND INELIGIBLE FOR WINDOW THERAPY Patients receive tirapazamine IV over 2 hours cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 1 4 10 19 and 28 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7 13 16 22 25 and 31 Patients also receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously SC beginning 1 day after each course of chemotherapy and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
PATIENTS WITH FAVORABLE RISK Patients receive cyclophosphamide IV over 1 hour and doxorubicin IV over 15-30 minutes on day 1 of weeks 1 4 10 19 and 28 Patients also receive ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 of weeks 7 13 16 22 25 and 31 Patients also receive G-CSF or GM-CSF SC beginning 1 day after each course of chemotherapy and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 4 months for 2 years and 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 |
|---|---|---|---|
| ARST0121 | None | None | None |
| U10CA098543 | NIH | None | None |
| CDR0000068954 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA098543 |