Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354744
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2006-07-19
Brief Title:
High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Intensive Multi-Agent Therapy Including Dose-Compressed Cycles of IfosfamideEtoposide IE and VincristineDoxorubicinCyclophosphamide VDC for Patients With High-Risk Rhabdomyosarcoma
Status:
COMPLETED
Status Verified Date:
2019-02
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 such as vincristine irinotecan ifosfamide etoposide doxorubicin cyclophosphamide and dactinomycin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells
PURPOSE This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma
PURPOSE This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma
Detailed Description:
OBJECTIVES
Primary
Improve the early disease control interval for patients with newly diagnosed high-risk metastatic rhabdomyosarcoma or ectomesenchymoma using intensive interval-compression therapy comprising vincristine irinotecan hydrochloride ifosfamide etoposide doxorubicin hydrochloride cyclophosphamide and dactinomycin that permits maximal early exposure to known effective agents
Determine the feasibility and assess immediate- and short-term side effects of concurrent irinotecan hydrochloride and radiotherapy in these patients
Secondary
Expand the available data for response to irinotecan hydrochloride and vincristine in previously untreated patients with high-risk rhabdomyosarcoma
Evaluate prospectively and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers
OUTLINE This is a prospective nonrandomized multicenter study Patients are stratified according to prognostic factors predictive of outcome eg histology bonebone marrow involvement and number of metastatic sites
Patients receive high-dose chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-5 7 8 11 12 15 16 20-24 28 29 32 33 35 38 41-44 47 48 50 and 51 irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 1 4 20 23 47 and 50 and ifosfamide IV over 1 hour and etoposide IV over 30-60 minutes on days 1-5 of weeks 9 13 17 26 and 30 Patients also receive doxorubicin hydrochloride IV continuously over 24 hours on days 1 and 2 of weeks 7 11 15 28 and 32 cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7 11 15 28 32 35 38 41 and 44 and dactinomycin IV over 1-5 minutes on day 1 of weeks 35 38 41 and 44 in the absence of disease progression or unacceptable toxicity Patients also receive filgrastim G-CSF subcutaneously in weeks 7-9 11-13 15-17 22 26 28-30 32 33 35 38 and 41-44 beginning 24-36 hours after the last chemotherapy dose and continuing until blood counts recover
NOTE Patients undergoing early radiotherapy for intracranial extension do not receive doxorubicin in week 7
Beginning at week 20 or week 1 for patients with parameningeal tumors with intracranial extension or spinal cord compression requiring emergency radiotherapy patients also undergo radiotherapy once a day 5 days a week for approximately 5½ weeks Some patients may also undergo second-look surgery
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
Primary
Improve the early disease control interval for patients with newly diagnosed high-risk metastatic rhabdomyosarcoma or ectomesenchymoma using intensive interval-compression therapy comprising vincristine irinotecan hydrochloride ifosfamide etoposide doxorubicin hydrochloride cyclophosphamide and dactinomycin that permits maximal early exposure to known effective agents
Determine the feasibility and assess immediate- and short-term side effects of concurrent irinotecan hydrochloride and radiotherapy in these patients
Secondary
Expand the available data for response to irinotecan hydrochloride and vincristine in previously untreated patients with high-risk rhabdomyosarcoma
Evaluate prospectively and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers
OUTLINE This is a prospective nonrandomized multicenter study Patients are stratified according to prognostic factors predictive of outcome eg histology bonebone marrow involvement and number of metastatic sites
Patients receive high-dose chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-5 7 8 11 12 15 16 20-24 28 29 32 33 35 38 41-44 47 48 50 and 51 irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 1 4 20 23 47 and 50 and ifosfamide IV over 1 hour and etoposide IV over 30-60 minutes on days 1-5 of weeks 9 13 17 26 and 30 Patients also receive doxorubicin hydrochloride IV continuously over 24 hours on days 1 and 2 of weeks 7 11 15 28 and 32 cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7 11 15 28 32 35 38 41 and 44 and dactinomycin IV over 1-5 minutes on day 1 of weeks 35 38 41 and 44 in the absence of disease progression or unacceptable toxicity Patients also receive filgrastim G-CSF subcutaneously in weeks 7-9 11-13 15-17 22 26 28-30 32 33 35 38 and 41-44 beginning 24-36 hours after the last chemotherapy dose and continuing until blood counts recover
NOTE Patients undergoing early radiotherapy for intracranial extension do not receive doxorubicin in week 7
Beginning at week 20 or week 1 for patients with parameningeal tumors with intracranial extension or spinal cord compression requiring emergency radiotherapy patients also undergo radiotherapy once a day 5 days a week for approximately 5½ weeks Some patients may also undergo second-look surgery
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
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-ARST0431 | OTHER | Childrens Oncology Group | None |
| CDR0000489215 | OTHER | None | None |