Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058461
Status:
TERMINATED
Last Update Posted:
2013-10-08
First Post:
2003-04-07
Brief Title:
Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkins Lymphoma or Acute Lymphoblastic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Rituximab IND 7028 and Ifosfamide Carboplatin and Etoposide ICE Chemotherapy in Children With RecurrentRefractory B-cell CD20 Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia
Status:
TERMINATED
Status Verified Date:
2013-10
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:
This phase II trial is studying how well rituximab together with ifosfamide carboplatin and etoposide works in treating young patients with recurrent or refractory non-Hodgkins lymphoma or acute lymphoblastic leukemia Chemotherapy drugs such as ifosfamide carboplatin and etoposide work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining ifosfamide carboplatin and etoposide with rituximab may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response of pediatric patients with relapsed or refractory B-cell non-Hodgkins lymphoma or acute lymphoblastic leukemia treated with ifosfamide carboplatin and etoposide combined with rituximab
II Determine the relapse-free survival rate of patients treated with this regimen
III Determine the toxicity profile of this regimen in these patients specifically the frequency of therapy delays between courses due to prolonged grade IV hematologic toxicity
SECONDARY OBJECTIVES
I Determine whether this regimen plus filgrastim G-CSF will result in mobilization of greater than 2 X 106kg peripheral blood stem cells CD34 cells PBSC in at least 80 of patients for whom peripheral stem cell collection is performed
II Determine the time course of engraftment for patients who undergo peripheral stem cell transplantation after collection of stem cells using this mobilization regimen
OUTLINE This is a multicenter study Patients are stratified by disease B-cell large cell lymphoma or atypical precursor B-cell lymphoblastic lymphoma vs small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia
Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5 rituximab IV on days 1 and 3 and carboplatin IV over 1 hour on day 3 Patients receive filgrastim G-CSF subcutaneously once daily beginning on day 6 and continuing until blood counts recover Patients also receive intrathecal IT chemotherapy comprising methotrexate and cytarabine Patients with B-cell large cell lymphoma and negative CSF cytology receive IT chemotherapy on day 3 of the first course only Patients with small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT chemotherapy on day 3 All patients with positive CSF cytology receive IT chemotherapy on days 3 10 and 17 of the first and second courses Treatment repeats every 23 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 42-82 patients 21-41 per disease stratum will be accrued for this study within 2-4 years
I Determine the response of pediatric patients with relapsed or refractory B-cell non-Hodgkins lymphoma or acute lymphoblastic leukemia treated with ifosfamide carboplatin and etoposide combined with rituximab
II Determine the relapse-free survival rate of patients treated with this regimen
III Determine the toxicity profile of this regimen in these patients specifically the frequency of therapy delays between courses due to prolonged grade IV hematologic toxicity
SECONDARY OBJECTIVES
I Determine whether this regimen plus filgrastim G-CSF will result in mobilization of greater than 2 X 106kg peripheral blood stem cells CD34 cells PBSC in at least 80 of patients for whom peripheral stem cell collection is performed
II Determine the time course of engraftment for patients who undergo peripheral stem cell transplantation after collection of stem cells using this mobilization regimen
OUTLINE This is a multicenter study Patients are stratified by disease B-cell large cell lymphoma or atypical precursor B-cell lymphoblastic lymphoma vs small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia
Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5 rituximab IV on days 1 and 3 and carboplatin IV over 1 hour on day 3 Patients receive filgrastim G-CSF subcutaneously once daily beginning on day 6 and continuing until blood counts recover Patients also receive intrathecal IT chemotherapy comprising methotrexate and cytarabine Patients with B-cell large cell lymphoma and negative CSF cytology receive IT chemotherapy on day 3 of the first course only Patients with small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT chemotherapy on day 3 All patients with positive CSF cytology receive IT chemotherapy on days 3 10 and 17 of the first and second courses Treatment repeats every 23 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 42-82 patients 21-41 per disease stratum will be accrued for this study within 2-4 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 |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2012-01804 | REGISTRY | None | None |
| COG-ANHL0121 | None | None | None |
| CDR0000298751 | None | None | None |
| ANHL0121 | OTHER | None | None |
| ANHL0121 | OTHER | None | None |