Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077285
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2004-02-10
Brief Title:
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Phase II Trial Of Irinotecan Plus Carboplatin And Irinotecan Maintenance Therapy High-Risk Patients Only Integrated Into The Upfront Therapy Of Newly Diagnosed Patients With Intermediate - And High-Risk Rhabdomyosarcoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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 such as irinotecan and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy first-line therapy works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma
PURPOSE This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy first-line therapy works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with newly diagnosed intermediate- or high-risk rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and carboplatin
Determine the acute toxic effects of this regimen combined with radiotherapy in these patients
Determine the safety and feasibility of this regimen in these patients
Determine the rate of local control achieved in patients treated with this regimen in combination with intensity-modulated radiotherapy
Determine the safety and feasibility of administering maintenance therapy comprising irinotecan to patients with high-risk rhabdomyosarcoma treated with this regimen
Secondary
Correlate preliminarily in vitro measurements of angiogenesis with clinical features extent of disease response to therapy and outcome in patients treated with this regimen
Determine preliminarily the efficacy of this regimen in terms of improved outcomes in these patients
OUTLINE This is a pilot study
Courses 1 and 2 Patients receive carboplatin IV over 1 hour on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for a total of 2 courses
Courses 3-5 Patients receive vincristine IV on days 1 8 and 15 dexrazoxane IV over 15-30 minutes doxorubicin IV over 15-30 minutes and cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim G-CSF subcutaneously SC once daily beginning on approximately day 3 and continuing until blood counts recover Treatment repeats every 21 days for a total of 3 courses
Some patients may undergo surgical resection of the tumor after completion of course 5 After course 5 patients undergo radiotherapy once daily 5 days a week for 4-55 weeks
Courses 6 and 7 Patients receive vincristine IV and carboplatin IV over 1 hour on day 1 irinotecan IV over 1 hour on days 1-5 and 8-12 and G-CSF SC once daily beginning on approximately day 13 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
NOTE Patients who develop disease progression during courses 1 or 2 do not receive further irinotecan and carboplatin Instead patients receive ifosfamide and etoposide as in courses 8 and 9
Courses 8 and 9 Patients receive vincristine IV on day 1 etoposide IV over 1 hour and ifosfamide IV over 2 hours on days 1-5 and G-CSF SC once daily beginning on approximately day 6 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
Course 10 Patients receive vincristine IV on days 1 8 15 22 29 36 and 43 dexrazoxane IV over 15-30 minutes doxorubicin IV over 15-30 minutes and cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim SC beginning on approximately day 3 and continuing until blood counts recover 1 course
Course 11 and 12 Patients receive etoposide IV over 1 hour and ifosfamide IV over 2 hours on days 1-5 and G-CSF SC once daily beginning on approximately day 6 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
Patients with high-risk disease proceed to maintenance therapy
Maintenance therapy Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for a total of 6 courses
NOTE Patients who develop disease progression during courses 1 or 2 do not receive further irinotecan
In all courses treatment continues in the absence of unacceptable toxicity or disease progression or recurrence after initial response
Patients are followed monthly for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
Starting with A8 patients will undergo PET Scans instead of Bone Scans at the discretion of the PI
Primary
Determine the response rate in patients with newly diagnosed intermediate- or high-risk rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and carboplatin
Determine the acute toxic effects of this regimen combined with radiotherapy in these patients
Determine the safety and feasibility of this regimen in these patients
Determine the rate of local control achieved in patients treated with this regimen in combination with intensity-modulated radiotherapy
Determine the safety and feasibility of administering maintenance therapy comprising irinotecan to patients with high-risk rhabdomyosarcoma treated with this regimen
Secondary
Correlate preliminarily in vitro measurements of angiogenesis with clinical features extent of disease response to therapy and outcome in patients treated with this regimen
Determine preliminarily the efficacy of this regimen in terms of improved outcomes in these patients
OUTLINE This is a pilot study
Courses 1 and 2 Patients receive carboplatin IV over 1 hour on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for a total of 2 courses
Courses 3-5 Patients receive vincristine IV on days 1 8 and 15 dexrazoxane IV over 15-30 minutes doxorubicin IV over 15-30 minutes and cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim G-CSF subcutaneously SC once daily beginning on approximately day 3 and continuing until blood counts recover Treatment repeats every 21 days for a total of 3 courses
Some patients may undergo surgical resection of the tumor after completion of course 5 After course 5 patients undergo radiotherapy once daily 5 days a week for 4-55 weeks
Courses 6 and 7 Patients receive vincristine IV and carboplatin IV over 1 hour on day 1 irinotecan IV over 1 hour on days 1-5 and 8-12 and G-CSF SC once daily beginning on approximately day 13 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
NOTE Patients who develop disease progression during courses 1 or 2 do not receive further irinotecan and carboplatin Instead patients receive ifosfamide and etoposide as in courses 8 and 9
Courses 8 and 9 Patients receive vincristine IV on day 1 etoposide IV over 1 hour and ifosfamide IV over 2 hours on days 1-5 and G-CSF SC once daily beginning on approximately day 6 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
Course 10 Patients receive vincristine IV on days 1 8 15 22 29 36 and 43 dexrazoxane IV over 15-30 minutes doxorubicin IV over 15-30 minutes and cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim SC beginning on approximately day 3 and continuing until blood counts recover 1 course
Course 11 and 12 Patients receive etoposide IV over 1 hour and ifosfamide IV over 2 hours on days 1-5 and G-CSF SC once daily beginning on approximately day 6 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses
Patients with high-risk disease proceed to maintenance therapy
Maintenance therapy Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for a total of 6 courses
NOTE Patients who develop disease progression during courses 1 or 2 do not receive further irinotecan
In all courses treatment continues in the absence of unacceptable toxicity or disease progression or recurrence after initial response
Patients are followed monthly for 1 year every 3 months for 1 year every 6 months for 1 year and then annually thereafter
Starting with A8 patients will undergo PET Scans instead of Bone Scans at the discretion of the PI
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 |
|---|---|---|---|
| MSKCC-03099 | None | None | None |