Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003093
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment for Infants and Children With Intermediate Risk Neuroblastoma A Phase III Intergroup CCGPOG Study
Status:
COMPLETED
Status Verified Date:
2014-07
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 Combining more than one drug may kill more tumor cells Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma
PURPOSE This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma
PURPOSE This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma
Detailed Description:
OBJECTIVES
Determine whether the use of selected prognostic variables to assign treatment increases the event-free survival and overall survival in children with intermediate-risk neuroblastoma
Determine the acute and long-term morbidity and toxicity of surgery and combination chemotherapy in this patient population
Assess the relationship between extent of tumor resection and event-free and overall survival in patients treated with this regimen
OUTLINE Patients receive carboplatin IV over 1 hour on days 0 21 and 63 cyclophosphamide IV over 1 hour on days 21 and 42 doxorubicin IV over 15-60 minutes on days 21 and 63 and etoposide IV over 2 hours on days 0-2 42-44 and 63-65 Patients under 60 days of age also receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning 24 hours after the last chemotherapy administration and continuing until blood counts recover Patients with favorable biology who do not achieve complete remission then undergo surgery to remove or debulk residual disease on day 84 or when blood counts recover Patients with favorable biology who achieve partial response and surgery to the primary site is not deemed in the best interest of the patient may receive additional chemotherapy as below and delay surgery to the primary site after completion of chemotherapy
Patients with unfavorable biology receive additional chemotherapy comprising cyclophosphamide IV over 1 hour on days 84 105 and 147 etoposide IV over 2 hours on days 84-86 and 126-128 carboplatin IV over 1 hour on days 105 and 126 and doxorubicin IV over 15-60 minutes on days 105 and 147 Patients then undergo debulking surgery on day 168 or when blood counts recover
Some patients may then undergo radiotherapy after surgery
Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
Determine whether the use of selected prognostic variables to assign treatment increases the event-free survival and overall survival in children with intermediate-risk neuroblastoma
Determine the acute and long-term morbidity and toxicity of surgery and combination chemotherapy in this patient population
Assess the relationship between extent of tumor resection and event-free and overall survival in patients treated with this regimen
OUTLINE Patients receive carboplatin IV over 1 hour on days 0 21 and 63 cyclophosphamide IV over 1 hour on days 21 and 42 doxorubicin IV over 15-60 minutes on days 21 and 63 and etoposide IV over 2 hours on days 0-2 42-44 and 63-65 Patients under 60 days of age also receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously beginning 24 hours after the last chemotherapy administration and continuing until blood counts recover Patients with favorable biology who do not achieve complete remission then undergo surgery to remove or debulk residual disease on day 84 or when blood counts recover Patients with favorable biology who achieve partial response and surgery to the primary site is not deemed in the best interest of the patient may receive additional chemotherapy as below and delay surgery to the primary site after completion of chemotherapy
Patients with unfavorable biology receive additional chemotherapy comprising cyclophosphamide IV over 1 hour on days 84 105 and 147 etoposide IV over 2 hours on days 84-86 and 126-128 carboplatin IV over 1 hour on days 105 and 126 and doxorubicin IV over 15-60 minutes on days 105 and 147 Patients then undergo debulking surgery on day 168 or when blood counts recover
Some patients may then undergo radiotherapy after surgery
Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 400 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 |
|---|---|---|---|
| CDR0000065804 | OTHER | Clinical Trialsgov | None |
| COG-A3961 | OTHER | None | None |
| CCG-A3961 | OTHER | None | None |
| POG-A3961 | OTHER | None | None |