Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025441
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
Sponsor:
Societe Internationale dOncologie Pediatrique
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood
Status:
COMPLETED
Status Verified Date:
2001-11
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 use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors
Detailed Description:
OBJECTIVES
Determine the overall survival of children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors treated with one of two different chemotherapy regimens based upon risk group
Determine the role of low-intensity maintenance chemotherapy after intensive conventional chemotherapy in standard-risk children
Determine the value of a therapeutic window in high-risk children
Determine the role of sequential high-dose chemotherapy with peripheral blood stem cell transplantation in achieving complete response in high-risk children
Determine the complete response overall survival and event-free survival in high-risk children
OUTLINE This is a multicenter study Patients are stratified according to risk group standard vs high
Standard-risk patients
Initial chemotherapy Patients receive vincristine IV on day 1 for weeks 1-7 Patients also receive dactinomycin IV on day 1 and ifosfamide IV over 1 hour on days 1-3 of week 1 Patients then receive carboplatin IV over 1 hour and epirubicin IV over 6 hours on day 1 of week 4 Patients then receive ifosfamide IV over 1 hour and etoposide IV over 4 hours on days 1-3 of week 7 Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity After the second course patients with less than 50 partial response PR are removed from study
Patients with parameningeal disease undergo radiotherapy 5 days a week for about 8 weeks beginning at week 9
Maintenance chemotherapy Patients receive cyclophosphamide IV over 1 hour vincristine IV and dactinomycin IV on day 1 Treatment repeats every 3 weeks for 9 courses in the absence of disease progression or unacceptable toxicity
Patients who remain in PR at week 17 undergo radiotherapy for about 9 weeks beginning at week 18
High-risk patients
Initial chemotherapy Patients receive window study drug carboplatin IV over 1 hour or doxorubicin on day 1 Treatment repeats every 3 weeks for 2 courses
Patients receive high-dose cyclophosphamide IV over 1 hour on days 1-3 of week 7 Beginning on day 8 patients receive filgrastim G-CSF IV or subcutaneously SC daily until day 13 Patients may undergo peripheral blood stem cell PBSC collection
Patients receive high-dose etoposide IV over 24 hours on days 15-17 Beginning on day 22 patients receive G-CSF IV or SC daily until day 27
Patients receive high-dose cyclophosphamide IV over 1 hour on days 29-31 Beginning on day 36 patients receive G-CSF IV or SC daily until day 42 Patients may undergo PBSC collection if not previously performed Patients who achieve complete response CR are removed from study
Patients receive high-dose carboplatin IV over 1 hour on days 44-48 Patients undergo PBSC reinfusion on day 52 Beginning on day 55 patients receive G-CSF IV or SC daily until blood counts recover
Maintenance chemotherapy Patients receive maintenance chemotherapy comprising cyclophosphamide vincristine and dactinomycin in the same manner as the standard-risk patients
Patients with parameningeal disease and those not achieving CR undergo radiotherapy beginning at week 17 Patients achieving CR unless metastatic disease is resected undergo radiotherapy beginning on week 15
Patients are followed every 2 months for 2 years every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 8-30 standard-risk patients will be accrued for this study within 4 years A total of 15-75 high-risk patients will be accrued for this study within 4-5 years
Determine the overall survival of children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors treated with one of two different chemotherapy regimens based upon risk group
Determine the role of low-intensity maintenance chemotherapy after intensive conventional chemotherapy in standard-risk children
Determine the value of a therapeutic window in high-risk children
Determine the role of sequential high-dose chemotherapy with peripheral blood stem cell transplantation in achieving complete response in high-risk children
Determine the complete response overall survival and event-free survival in high-risk children
OUTLINE This is a multicenter study Patients are stratified according to risk group standard vs high
Standard-risk patients
Initial chemotherapy Patients receive vincristine IV on day 1 for weeks 1-7 Patients also receive dactinomycin IV on day 1 and ifosfamide IV over 1 hour on days 1-3 of week 1 Patients then receive carboplatin IV over 1 hour and epirubicin IV over 6 hours on day 1 of week 4 Patients then receive ifosfamide IV over 1 hour and etoposide IV over 4 hours on days 1-3 of week 7 Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity After the second course patients with less than 50 partial response PR are removed from study
Patients with parameningeal disease undergo radiotherapy 5 days a week for about 8 weeks beginning at week 9
Maintenance chemotherapy Patients receive cyclophosphamide IV over 1 hour vincristine IV and dactinomycin IV on day 1 Treatment repeats every 3 weeks for 9 courses in the absence of disease progression or unacceptable toxicity
Patients who remain in PR at week 17 undergo radiotherapy for about 9 weeks beginning at week 18
High-risk patients
Initial chemotherapy Patients receive window study drug carboplatin IV over 1 hour or doxorubicin on day 1 Treatment repeats every 3 weeks for 2 courses
Patients receive high-dose cyclophosphamide IV over 1 hour on days 1-3 of week 7 Beginning on day 8 patients receive filgrastim G-CSF IV or subcutaneously SC daily until day 13 Patients may undergo peripheral blood stem cell PBSC collection
Patients receive high-dose etoposide IV over 24 hours on days 15-17 Beginning on day 22 patients receive G-CSF IV or SC daily until day 27
Patients receive high-dose cyclophosphamide IV over 1 hour on days 29-31 Beginning on day 36 patients receive G-CSF IV or SC daily until day 42 Patients may undergo PBSC collection if not previously performed Patients who achieve complete response CR are removed from study
Patients receive high-dose carboplatin IV over 1 hour on days 44-48 Patients undergo PBSC reinfusion on day 52 Beginning on day 55 patients receive G-CSF IV or SC daily until blood counts recover
Maintenance chemotherapy Patients receive maintenance chemotherapy comprising cyclophosphamide vincristine and dactinomycin in the same manner as the standard-risk patients
Patients with parameningeal disease and those not achieving CR undergo radiotherapy beginning at week 17 Patients achieving CR unless metastatic disease is resected undergo radiotherapy beginning on week 15
Patients are followed every 2 months for 2 years every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 8-30 standard-risk patients will be accrued for this study within 4 years A total of 15-75 high-risk patients will be accrued for this study within 4-5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STS-1998 | None | None | None |
| SIOP-MMT-98 | None | None | None |
| SFOP-SIOP-MMT-98 | None | None | None |
| CCLG-SIOP-MMT-98 | None | None | None |
| EU-20126 | None | None | None |