Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061893
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2003-06-05
Brief Title:
Vinblastine Celecoxib and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewings Sarcoma Family of Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study of Low-Dose Antiangiogenic Chemotherapy in Combination With Standard Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma Family of Tumors
Status:
COMPLETED
Status Verified Date:
2019-01
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:
RATIONALE Drugs used in chemotherapy such as vinblastine work in different ways to stop tumor cells from dividing so they stop growing or die Celecoxib may stop the growth of Ewings sarcoma by stopping blood flow to the tumor Combining more than one chemotherapy drug with celecoxib may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining low-dose vinblastine and celecoxib with standard regimens of combination chemotherapy in treating patients who have newly-diagnosed metastatic Ewings sarcoma family of tumors
PURPOSE Phase II trial to study the effectiveness of combining low-dose vinblastine and celecoxib with standard regimens of combination chemotherapy in treating patients who have newly-diagnosed metastatic Ewings sarcoma family of tumors
Detailed Description:
OBJECTIVES
Determine the feasibility and safety of low-dose vinblastine and celecoxib in combination with standard multiagent chemotherapy in patients with newly diagnosed metastatic Ewings sarcoma family of tumors
Determine the event-free survival of patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a pilot multicenter study
Induction therapy Patients receive the following alternating regimens
VAC courses 1 and 3 Patients receive vincristine IV and cyclophosphamide IV over 1 hour on day 1 and doxorubicin IV continuously on days 1 and 2 of weeks 1 and 7
IE courses 2 and 4 Patients receive ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 4 and 10
Patients also receive filgrastim G-CSF subcutaneously SC beginning 24-48 hours after the last dose of chemotherapy and continuing until blood counts recover
Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Local control and consolidation therapy Beginning on week 13 patients are assigned to 1 of 4 regimens based on disease status
Regimen A surgery only Patients who respond to induction chemotherapy undergo surgery on week 13 Patients then begin consolidation therapy on week 15 with the following alternating regimens
VAC courses 5 7 and 9 Patients receive VAC on weeks 15 21 and 27
IE courses 6 8 10 12 and 14 Patients receive IE on weeks 18 24 30 36 and 42
VC courses 11 and 13 Patients receive vincristine IV and cyclophosphamide IV over 1 hour on weeks 33 and 39
Regimen B radiotherapy only Patients with unresectable lesions undergo radiotherapy once daily 5 days a week for up to approximately 6 weeks beginning on week 13 Patients also receive consolidation therapy beginning on week 13 with the following alternating regimens
VAC courses 5 9 and 11 Patients receive VAC on weeks 13 25 and 31
IE courses 6 8 10 12 and 14 Patients receive IE on weeks 16 22 28 34 and 40
VC courses 7 and 13 Patients receive VC on weeks 19 and 37
Regimen C surgery and radiotherapy Patients who respond to induction chemotherapy undergo surgery on week 13 Patients who have inadequate margins after surgery undergo radiotherapy as in regimen B beginning on week 15 Patients also receive consolidation therapy beginning on week 15 with the following alternating regimens
VAC courses 5 9 and 11 Patients receive VAC on weeks 15 27 and 33
IE courses 6 8 10 12 and 14 Patients receive IE on weeks 18 24 30 36 and 42
VC courses 7 and 13 Patients receive VC on weeks 21 and 39
Regimen D preoperative radiotherapy Patients with bulky lesions who do not have a good clinical and radiographic response to induction therapy begin consolidation therapy on week 13 with VAC course 5 and undergo concurrent radiotherapy as in regimen B Patients then receive IE on weeks 16 and 19 for courses 6 and 7 Patients undergo surgery on week 22 Patients continue consolidation therapy with the following alternating regimens
VAC courses 8 and 9 Patients receive VAC on weeks 24 and 27
IE courses 10 12 and 14 Patients receive IE on weeks 30 36 and 42
VC courses 11 and 13 Patients receive VC on weeks 33 and 39 Patients receive G-CSF SC as in induction therapy during all consolidation courses
Consolidation therapy continues for 10 courses in the absence of disease progression or unacceptable toxicity
Vinblastine and celecoxib therapy Throughout induction local control and consolidation therapies patients also receive vinblastine IV 3 times a week twice a week during the weeks that vincristine is given and oral celecoxib twice daily beginning on day 1 of course 1 and continuing until the completion of course 14 NOTE To assess for safety the first 6 patients enrolled receive vinblastine only during courses 1 and 2 and celecoxib is then added for all subsequent courses
Patients are followed every 3 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 6-36 patients will be accrued for this study within 117 years
Determine the feasibility and safety of low-dose vinblastine and celecoxib in combination with standard multiagent chemotherapy in patients with newly diagnosed metastatic Ewings sarcoma family of tumors
Determine the event-free survival of patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a pilot multicenter study
Induction therapy Patients receive the following alternating regimens
VAC courses 1 and 3 Patients receive vincristine IV and cyclophosphamide IV over 1 hour on day 1 and doxorubicin IV continuously on days 1 and 2 of weeks 1 and 7
IE courses 2 and 4 Patients receive ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 4 and 10
Patients also receive filgrastim G-CSF subcutaneously SC beginning 24-48 hours after the last dose of chemotherapy and continuing until blood counts recover
Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Local control and consolidation therapy Beginning on week 13 patients are assigned to 1 of 4 regimens based on disease status
Regimen A surgery only Patients who respond to induction chemotherapy undergo surgery on week 13 Patients then begin consolidation therapy on week 15 with the following alternating regimens
VAC courses 5 7 and 9 Patients receive VAC on weeks 15 21 and 27
IE courses 6 8 10 12 and 14 Patients receive IE on weeks 18 24 30 36 and 42
VC courses 11 and 13 Patients receive vincristine IV and cyclophosphamide IV over 1 hour on weeks 33 and 39
Regimen B radiotherapy only Patients with unresectable lesions undergo radiotherapy once daily 5 days a week for up to approximately 6 weeks beginning on week 13 Patients also receive consolidation therapy beginning on week 13 with the following alternating regimens
VAC courses 5 9 and 11 Patients receive VAC on weeks 13 25 and 31
IE courses 6 8 10 12 and 14 Patients receive IE on weeks 16 22 28 34 and 40
VC courses 7 and 13 Patients receive VC on weeks 19 and 37
Regimen C surgery and radiotherapy Patients who respond to induction chemotherapy undergo surgery on week 13 Patients who have inadequate margins after surgery undergo radiotherapy as in regimen B beginning on week 15 Patients also receive consolidation therapy beginning on week 15 with the following alternating regimens
VAC courses 5 9 and 11 Patients receive VAC on weeks 15 27 and 33
IE courses 6 8 10 12 and 14 Patients receive IE on weeks 18 24 30 36 and 42
VC courses 7 and 13 Patients receive VC on weeks 21 and 39
Regimen D preoperative radiotherapy Patients with bulky lesions who do not have a good clinical and radiographic response to induction therapy begin consolidation therapy on week 13 with VAC course 5 and undergo concurrent radiotherapy as in regimen B Patients then receive IE on weeks 16 and 19 for courses 6 and 7 Patients undergo surgery on week 22 Patients continue consolidation therapy with the following alternating regimens
VAC courses 8 and 9 Patients receive VAC on weeks 24 and 27
IE courses 10 12 and 14 Patients receive IE on weeks 30 36 and 42
VC courses 11 and 13 Patients receive VC on weeks 33 and 39 Patients receive G-CSF SC as in induction therapy during all consolidation courses
Consolidation therapy continues for 10 courses in the absence of disease progression or unacceptable toxicity
Vinblastine and celecoxib therapy Throughout induction local control and consolidation therapies patients also receive vinblastine IV 3 times a week twice a week during the weeks that vincristine is given and oral celecoxib twice daily beginning on day 1 of course 1 and continuing until the completion of course 14 NOTE To assess for safety the first 6 patients enrolled receive vinblastine only during courses 1 and 2 and celecoxib is then added for all subsequent courses
Patients are followed every 3 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 6-36 patients will be accrued for this study within 117 years
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 |
|---|---|---|---|
| CDR0000302409 | REGISTRY | PDQ Physician Data Query | None |