Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040690
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy in Treating Patients With Burkitts Lymphoma or Burkitts Leukemia
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Clinicopathological Study In Burkittss And Burkitt-Like Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2007-05
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 patients who have Burkitts lymphoma or Burkitts leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Burkitts lymphoma or Burkitts leukemia
Detailed Description:
OBJECTIVES
Describe the morphology phenotype and cytogenetics using fresh tumor tissue when possible in patients with Burkitts or Burkitt-like lymphomaleukemia treated with the CODOX-M chemotherapy regimen cyclophosphamide vincristine doxorubicin and methotrexate alone or alternating with the IVAC chemotherapy regimen ifosfamide etoposide and cytarabine
Determine whether cytogenetic and molecular changes are associated with or predictable from the immunophenotype of the tumor cells or patient characteristics eg age
Examine the relationship between t1418 and bcl-2 expression in patients treated with this regimen
Determine whether the presence of specific cytogenetic and molecular changes in particular the presence of t1418 and t814 is associated with an adverse outcome progression-free and overall survival in patients treated with this regimen
Assess the activity of the alternating CODOX-MIVAC chemotherapy regimens using a lower dose of methotrexate compared to the UKLG LY06 trial in these patients
Assess further the activity of these regimens in patients with leukemic Burkitts lymphoma
Modify the chemotherapy doses in these regimens to include older patients who are often excluded from clinical trials
OUTLINE This is a multicenter study Patients with low-risk disease are assigned to group A while patients with high-risk disease are assigned to group B
Group A low-risk group
Patients receive 3 courses of the CODOX-M chemotherapy regimen comprising cyclophosphamide IV on days 1-5 vincristine IV on days 1 and 8 doxorubicin IV on day 1 and methotrexate MTX IV over 24 hours on day 10 Patients over age 65 receive reduced-dose MTX on day 10 All patients receive leucovorin calcium CF IV once at hour 36 after initiation of MTX infusion once every 3 hours between hours 36-48 and continuing once every 6 hours until blood levels of MTX are safe Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 13 and continuing until blood counts recover
During all 3 courses of the CODOX-M regimen patients receive CNS prophylaxis comprising cytarabine ARA-C intrathecally IT on days 1 and 3 MTX IT on day 15 and oral CF 24 hours after IT MTX on day 16
Group B high-risk group
Patients receive the CODOX-M chemotherapy regimen as above alternating with the IVAC chemotherapy regimen as defined below for a total of 4 courses given in the following sequence CODOX-M IVAC CODOX-M and IVAC The IVAC chemotherapy regimen comprises ifosfamide IFF IV over 1 hour and etoposide IV over 1 hour on days 1-5 and ARA-C IV over 3 hours on days 1 and 2 Patients over age 65 receive reduced-dose IFF and ARA-C Patients also receive G-CSF SC once daily beginning on day 7 and continuing until blood counts recover
During IVAC patients without CNS disease receive MTX IT on day 5 and oral CF 24 hours after MTX Patients with proven CNS disease receive intensified IT therapy throughout the first two courses of CODOX-MIVAC chemotherapy
For patients in group B with CNS disease at diagnosis radiotherapy is only considered in the presence of a cerebral mass documented by CT scan or MRI Patients in group A or B who develop isolated CNS recurrence documented by malignant CSF pleocytosis cranial nerve palsies or both at any time after the first course of study therapy receive the same CNS treatment as above as patients with proven CNS disease in addition to whole brain irradiation for 3 weeks
Patients are followed monthly for 4 months every 2 months for 8 months every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A minimum of 120 patients 30 with low-risk disease and 90 with high-risk disease will be accrued for this study within approximately 3-4 years
Describe the morphology phenotype and cytogenetics using fresh tumor tissue when possible in patients with Burkitts or Burkitt-like lymphomaleukemia treated with the CODOX-M chemotherapy regimen cyclophosphamide vincristine doxorubicin and methotrexate alone or alternating with the IVAC chemotherapy regimen ifosfamide etoposide and cytarabine
Determine whether cytogenetic and molecular changes are associated with or predictable from the immunophenotype of the tumor cells or patient characteristics eg age
Examine the relationship between t1418 and bcl-2 expression in patients treated with this regimen
Determine whether the presence of specific cytogenetic and molecular changes in particular the presence of t1418 and t814 is associated with an adverse outcome progression-free and overall survival in patients treated with this regimen
Assess the activity of the alternating CODOX-MIVAC chemotherapy regimens using a lower dose of methotrexate compared to the UKLG LY06 trial in these patients
Assess further the activity of these regimens in patients with leukemic Burkitts lymphoma
Modify the chemotherapy doses in these regimens to include older patients who are often excluded from clinical trials
OUTLINE This is a multicenter study Patients with low-risk disease are assigned to group A while patients with high-risk disease are assigned to group B
Group A low-risk group
Patients receive 3 courses of the CODOX-M chemotherapy regimen comprising cyclophosphamide IV on days 1-5 vincristine IV on days 1 and 8 doxorubicin IV on day 1 and methotrexate MTX IV over 24 hours on day 10 Patients over age 65 receive reduced-dose MTX on day 10 All patients receive leucovorin calcium CF IV once at hour 36 after initiation of MTX infusion once every 3 hours between hours 36-48 and continuing once every 6 hours until blood levels of MTX are safe Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 13 and continuing until blood counts recover
During all 3 courses of the CODOX-M regimen patients receive CNS prophylaxis comprising cytarabine ARA-C intrathecally IT on days 1 and 3 MTX IT on day 15 and oral CF 24 hours after IT MTX on day 16
Group B high-risk group
Patients receive the CODOX-M chemotherapy regimen as above alternating with the IVAC chemotherapy regimen as defined below for a total of 4 courses given in the following sequence CODOX-M IVAC CODOX-M and IVAC The IVAC chemotherapy regimen comprises ifosfamide IFF IV over 1 hour and etoposide IV over 1 hour on days 1-5 and ARA-C IV over 3 hours on days 1 and 2 Patients over age 65 receive reduced-dose IFF and ARA-C Patients also receive G-CSF SC once daily beginning on day 7 and continuing until blood counts recover
During IVAC patients without CNS disease receive MTX IT on day 5 and oral CF 24 hours after MTX Patients with proven CNS disease receive intensified IT therapy throughout the first two courses of CODOX-MIVAC chemotherapy
For patients in group B with CNS disease at diagnosis radiotherapy is only considered in the presence of a cerebral mass documented by CT scan or MRI Patients in group A or B who develop isolated CNS recurrence documented by malignant CSF pleocytosis cranial nerve palsies or both at any time after the first course of study therapy receive the same CNS treatment as above as patients with proven CNS disease in addition to whole brain irradiation for 3 weeks
Patients are followed monthly for 4 months every 2 months for 8 months every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A minimum of 120 patients 30 with low-risk disease and 90 with high-risk disease will be accrued for this study within approximately 3-4 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 |
|---|---|---|---|
| EU-20117 | None | None | None |
| MRC-LY10 | None | None | None |