Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392990
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2006-10-25
Brief Title:
Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitts Lymphoma or Burkitt-Like Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Multicenter Phase II Study Incorporating DOXIL and Rituximab Into the Magrath Regimen for HIV-Negative and HIV-Positive Patients With Newly Diagnosed Burkitts and Burkitt-like Lymphoma
Status:
COMPLETED
Status Verified Date:
2019-08
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 doxorubicin hydrochloride liposome work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving rituximab together with combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving doxorubicin hydrochloride liposome and rituximab together with combination chemotherapy works in treating patients with newly diagnosed Burkitts lymphoma or Burkitt-like lymphoma
PURPOSE This phase II trial is studying how well giving doxorubicin hydrochloride liposome and rituximab together with combination chemotherapy works in treating patients with newly diagnosed Burkitts lymphoma or Burkitt-like lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the overall response rate complete remission complete remission undetermined and partial remission in HIV-negative or HIV-positive patients with newly diagnosed Burkitts or Burkitt-like lymphoma treated with doxorubicin hydrochloride liposome and rituximab as part of the Magrath regimen
Secondary
Determine the complete remission rate in patients treated with this regimen
Determine progression-free and overall survival at 2 years in patients treated with this regimen
Determine the safety of adding rituximab to the standard Magrath regimen in these patients
Determine the safety of using doxorubicin hydrochloride liposome in place of doxorubicin hydrochloride in these patients
Determine correlative levels of rituximab and doxorubicin hydrochloride liposome in cerebrospinal fluid and peripheral blood
OUTLINE This is a multicenter study Patients are stratified according to risk category low risk vs high risk Patients are assigned to 1 of 2 treatment regimens according to stratum
Regimen A low-risk disease with no CNS involvement Patients receive R-CODOX-M chemotherapy comprising rituximab IV over 2-4 hours on days 0 and 8 doxorubicin hydrochloride liposome IV over 30 minutes on day 1 vincristine IV on days 1 and 8 cyclophosphamide IV over 1 hour on days 1-5 and high-dose methotrexate MTX IV over 24 hours on day 10 Patients also receive leucovorin calcium IV beginning 36 hours after the start of MTX infusion and continuing every 6 hours until blood levels of MTX are safe Patients also receive filgrastim G-CSF subcutaneously SC once daily on days 4-8 in courses 1 and 3 and on days 6 and 7 in course 2 Beginning on day 12 daily G-CSF dosing resumes until blood counts recover Patients receive CNS prophylaxis comprising cytarabine intrathecally IT on day 1 and MTX IT on day 3 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Regimen B high-risk disease with or without CNS involvement Patients receive R-CODOX-M chemotherapy with leucovorin calcium and G-CSF support as in regimen A for courses 1 and 3 and R-IVAC chemotherapy with leucovorin calcium and G-CSF support as below for courses 2 and 4 R-IVAC chemotherapy comprises high-dose ifosfamide IV over 3 hours and etoposide IV over 1 hour on days 1-5 cytarabine IV over 3 hours twice daily on days 2 and 3 and rituximab IV over 2-4 hours on day 0 and on day 6 or 7 Patients also receive leucovorin calcium orally every 6 hours on day 6 and G-CSF SC once daily beginning on day 6 or 7 and continuing until blood counts recover Patients without CNS involvement receive CNS prophylaxis comprising cytarabine IT on days 1 and 3 and MTX IT on day 15 in courses 1 and 3 and MTX IT alone on day 5 in courses 2 and 4 Patients with proven CNS involvement at diagnosis receive cytarabine IT on days 1 3 and 5 in course 1 on days 7 and 9 in course 2 and on days 1 and 3 in course 3 These patients also receive MTX IT on days 15 and 17 in course 1 on day 5 in courses 2 and 4 and on day 15 in course 3 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
The first 10 patients enrolled on the study undergo cerebrospinal fluid and blood collection during courses 1 and 3 for correlative biological marker and pharmacological studies
After completion of study treatment patients are followed at 30 days and then periodically for up to 3 years
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Primary
Determine the overall response rate complete remission complete remission undetermined and partial remission in HIV-negative or HIV-positive patients with newly diagnosed Burkitts or Burkitt-like lymphoma treated with doxorubicin hydrochloride liposome and rituximab as part of the Magrath regimen
Secondary
Determine the complete remission rate in patients treated with this regimen
Determine progression-free and overall survival at 2 years in patients treated with this regimen
Determine the safety of adding rituximab to the standard Magrath regimen in these patients
Determine the safety of using doxorubicin hydrochloride liposome in place of doxorubicin hydrochloride in these patients
Determine correlative levels of rituximab and doxorubicin hydrochloride liposome in cerebrospinal fluid and peripheral blood
OUTLINE This is a multicenter study Patients are stratified according to risk category low risk vs high risk Patients are assigned to 1 of 2 treatment regimens according to stratum
Regimen A low-risk disease with no CNS involvement Patients receive R-CODOX-M chemotherapy comprising rituximab IV over 2-4 hours on days 0 and 8 doxorubicin hydrochloride liposome IV over 30 minutes on day 1 vincristine IV on days 1 and 8 cyclophosphamide IV over 1 hour on days 1-5 and high-dose methotrexate MTX IV over 24 hours on day 10 Patients also receive leucovorin calcium IV beginning 36 hours after the start of MTX infusion and continuing every 6 hours until blood levels of MTX are safe Patients also receive filgrastim G-CSF subcutaneously SC once daily on days 4-8 in courses 1 and 3 and on days 6 and 7 in course 2 Beginning on day 12 daily G-CSF dosing resumes until blood counts recover Patients receive CNS prophylaxis comprising cytarabine intrathecally IT on day 1 and MTX IT on day 3 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Regimen B high-risk disease with or without CNS involvement Patients receive R-CODOX-M chemotherapy with leucovorin calcium and G-CSF support as in regimen A for courses 1 and 3 and R-IVAC chemotherapy with leucovorin calcium and G-CSF support as below for courses 2 and 4 R-IVAC chemotherapy comprises high-dose ifosfamide IV over 3 hours and etoposide IV over 1 hour on days 1-5 cytarabine IV over 3 hours twice daily on days 2 and 3 and rituximab IV over 2-4 hours on day 0 and on day 6 or 7 Patients also receive leucovorin calcium orally every 6 hours on day 6 and G-CSF SC once daily beginning on day 6 or 7 and continuing until blood counts recover Patients without CNS involvement receive CNS prophylaxis comprising cytarabine IT on days 1 and 3 and MTX IT on day 15 in courses 1 and 3 and MTX IT alone on day 5 in courses 2 and 4 Patients with proven CNS involvement at diagnosis receive cytarabine IT on days 1 3 and 5 in course 1 on days 7 and 9 in course 2 and on days 1 and 3 in course 3 These patients also receive MTX IT on days 15 and 17 in course 1 on day 5 in courses 2 and 4 and on day 15 in course 3 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
The first 10 patients enrolled on the study undergo cerebrospinal fluid and blood collection during courses 1 and 3 for correlative biological marker and pharmacological studies
After completion of study treatment patients are followed at 30 days and then periodically for up to 3 years
PROJECTED ACCRUAL A total of 25 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 |
|---|---|---|---|
| STU00004480 | OTHER | Northwestern University IRB | httpsreporternihgovquickSearchP30CA060553 |
| P30CA060553 | NIH | None | None |
| NU 06H2 | OTHER | None | None |
| NU-1346-018 | None | None | None |
| ORTHO-NU-06H2 | None | None | None |
| CDR0000509706 | REGISTRY | None | None |