Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003955
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Up-Front Window Study of Irinotecan CPT-11 Followed by Multimodal Multiagent Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4Clinical Group IV Rhabdomyosarcoma An IRS-V Study
Status:
COMPLETED
Status Verified Date:
2014-02
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma
Detailed Description:
OBJECTIVES
Determine the response rate of patients with newly diagnosed high-risk metastatic stage IVclinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine
Determine the toxic effects of this regimen in these patients
Determine the toxic effects of this regimen when given in alternating courses with vincristine dactinomycin and cyclophosphamide VAC as continuation therapy in patients with partial or complete response
Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy
Determine the pharmacokinetics of irinotecan and vincristine in these patients
OUTLINE
Upfront window therapy Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12 Treatment repeats every 21 days for a total of 2 courses Patients experiencing partial or complete response proceed to regimen A Patients experiencing stable or progressive disease proceed to regimen B
Regimen A Patients receive vincristine IV over 1 minute weekly on weeks 6-13 15-19 23-27 29 32-35 38-39 and 41 dactinomycin IV over 1 minute weekly on weeks 6 12 23 29 35 and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6 12 16 19 23 29 35 and 41 Patients also receive irinotecan IV over 1 hour daily 5 days a week on weeks 9 10 26 27 32 33 38 and 39 and undergo radiotherapy daily 5 days a week on weeks 15-22
Regimen B Patients receive vincristine as in regimen A dactinomycin IV over 1 minute weekly on weeks 6 9 12 23 26 29 32 35 38 and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6 9 12 16 19 23 26 29 32 35 38 and 41 Patients receive radiotherapy as in regimen A
Patients who do not receive upfront window irinotecanvincristine therapy are treated with standard therapy
Standard therapy Patients receive vincristine IV over 1 minute weekly on weeks 0-13 15-19 23-27 29 32-35 38 and 41 dactinomycin IV over 1 minute weekly on weeks 0 6 9 12 23 26 29 32 35 38 and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 0 3 6 9 12 16 19 23 26 29 32 35 38 and 41 Patients without evidence of intracranial extension receive radiotherapy once daily 5 days a week during weeks 15-22 Patients with evidence of intracranial extension or who require emergency radiotherapy receive radiotherapy during weeks 0-6 Dactinomycin is withheld during radiotherapy
All patients receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously SC beginning 24 hours after completion of each course of chemotherapy and continuing until blood counts recover Alternatively patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover
Patients are followed every 2 months for 1 year every 4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 9-24 months
Determine the response rate of patients with newly diagnosed high-risk metastatic stage IVclinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine
Determine the toxic effects of this regimen in these patients
Determine the toxic effects of this regimen when given in alternating courses with vincristine dactinomycin and cyclophosphamide VAC as continuation therapy in patients with partial or complete response
Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy
Determine the pharmacokinetics of irinotecan and vincristine in these patients
OUTLINE
Upfront window therapy Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12 Treatment repeats every 21 days for a total of 2 courses Patients experiencing partial or complete response proceed to regimen A Patients experiencing stable or progressive disease proceed to regimen B
Regimen A Patients receive vincristine IV over 1 minute weekly on weeks 6-13 15-19 23-27 29 32-35 38-39 and 41 dactinomycin IV over 1 minute weekly on weeks 6 12 23 29 35 and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6 12 16 19 23 29 35 and 41 Patients also receive irinotecan IV over 1 hour daily 5 days a week on weeks 9 10 26 27 32 33 38 and 39 and undergo radiotherapy daily 5 days a week on weeks 15-22
Regimen B Patients receive vincristine as in regimen A dactinomycin IV over 1 minute weekly on weeks 6 9 12 23 26 29 32 35 38 and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6 9 12 16 19 23 26 29 32 35 38 and 41 Patients receive radiotherapy as in regimen A
Patients who do not receive upfront window irinotecanvincristine therapy are treated with standard therapy
Standard therapy Patients receive vincristine IV over 1 minute weekly on weeks 0-13 15-19 23-27 29 32-35 38 and 41 dactinomycin IV over 1 minute weekly on weeks 0 6 9 12 23 26 29 32 35 38 and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 0 3 6 9 12 16 19 23 26 29 32 35 38 and 41 Patients without evidence of intracranial extension receive radiotherapy once daily 5 days a week during weeks 15-22 Patients with evidence of intracranial extension or who require emergency radiotherapy receive radiotherapy during weeks 0-6 Dactinomycin is withheld during radiotherapy
All patients receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously SC beginning 24 hours after completion of each course of chemotherapy and continuing until blood counts recover Alternatively patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover
Patients are followed every 2 months for 1 year every 4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 9-24 months
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 |
|---|---|---|---|
| CDR0000067154 | OTHER | Clinical Trialsgov | None |
| COG-D9802 | OTHER | None | None |
| IRS-D9802 | OTHER | None | None |
| CCG-D9802 | OTHER | None | None |
| POG-D9802 | OTHER | None | None |