Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002618
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Study of Large Cell Lymphomas in Children and Adolescents Comparison of APO vs APO IDMTXHDARA-C and Continuous vs Bolus Infusion of Doxorubicin
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 cancer cells from dividing so they stop growing or die Giving the drugs in different doses may kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma
Detailed Description:
OBJECTIVES I Compare the event free survival of children with advanced stage large cell lymphoma treated with modified APO doxorubicinprednisonevincristinemercaptopurine with or without intermediate-dose methotrexatehigh dose cytarabine as maintenance therapy following induction therapy with APO II Characterize further the immunophenotypic and morphologic correlates of pediatric large cell lymphoma
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms except for those with CNS disease These patients are assigned to arm II and receive whole brain irradiation on Regimen B Arm I Induction Modified APO Patients receive vincristine IV on days 1 8 15 22 and 29 doxorubicin IV over 15 minutes on days 1 and 22 prednisone three times a day on days 1-28 and methotrexate intrathecally IT on days 1 8 and 22 Patients in complete remission on day 43 proceed to maintenance those in partial remission undergo biopsy then proceed to maintenance and those with residual disease receive radiotherapy on regimen A concurrently with maintenance Maintenance day 1 is day 43 of Induction Courses of intermediate dose methotrexateleucovorin calcium and high dose cytarabine ID MTXCFHD ARA-C and modified APO alternate every 3 weeks Patients receive a total of 15 courses 8 of ID MTXCFHD ARA-C and 7 of Modified APO ID MTXCFHD ARA-C Patients receive methotrexate IV over 24 hours on day 1 leucovorin calcium IV or orally every 6 hours on days 2 and 3 cytarabine IV over 48 hours on days 2 to 4 and methotrexate IT on day 1 of courses 1 3 and 5 Filgrastim G-CSF is administered beginning on day 5 and continuing until blood counts recover Modified APO Patients receive vincristine IV on day 1 oral mercaptopurine on days 1-5 doxorubicin IV over 15 minutes on day 1 and oral prednisone three times a day on days 1-5 Arm II Induction Patients receive treatment as in arm I except that patients with CNS disease also receive methotrexate IT on days 15 29 and 36 Maintenance day 1 is day 43 of Induction Modified APO as in Arm I with methotrexate administered on day 1 of courses 1 3 and 5 days 1-5 for patients with CNS disease Courses repeat every 21 days for a total of 15 courses Patients with CNS disease begin radiotherapy on Regimen B on week 2 of maintenance Regimen A Patients begin radiotherapy 5 days a week for 45 weeks to residual tumor on day 1 of maintenance Regimen B Patients receive whole brain irradiation 5 days a week for 31 weeks beginning on day 1 of maintenance Patients are followed monthly for 6 months every 3 months for 18 months every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL A total of 242 patients will be accrued for this study over approximately 54 years
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms except for those with CNS disease These patients are assigned to arm II and receive whole brain irradiation on Regimen B Arm I Induction Modified APO Patients receive vincristine IV on days 1 8 15 22 and 29 doxorubicin IV over 15 minutes on days 1 and 22 prednisone three times a day on days 1-28 and methotrexate intrathecally IT on days 1 8 and 22 Patients in complete remission on day 43 proceed to maintenance those in partial remission undergo biopsy then proceed to maintenance and those with residual disease receive radiotherapy on regimen A concurrently with maintenance Maintenance day 1 is day 43 of Induction Courses of intermediate dose methotrexateleucovorin calcium and high dose cytarabine ID MTXCFHD ARA-C and modified APO alternate every 3 weeks Patients receive a total of 15 courses 8 of ID MTXCFHD ARA-C and 7 of Modified APO ID MTXCFHD ARA-C Patients receive methotrexate IV over 24 hours on day 1 leucovorin calcium IV or orally every 6 hours on days 2 and 3 cytarabine IV over 48 hours on days 2 to 4 and methotrexate IT on day 1 of courses 1 3 and 5 Filgrastim G-CSF is administered beginning on day 5 and continuing until blood counts recover Modified APO Patients receive vincristine IV on day 1 oral mercaptopurine on days 1-5 doxorubicin IV over 15 minutes on day 1 and oral prednisone three times a day on days 1-5 Arm II Induction Patients receive treatment as in arm I except that patients with CNS disease also receive methotrexate IT on days 15 29 and 36 Maintenance day 1 is day 43 of Induction Modified APO as in Arm I with methotrexate administered on day 1 of courses 1 3 and 5 days 1-5 for patients with CNS disease Courses repeat every 21 days for a total of 15 courses Patients with CNS disease begin radiotherapy on Regimen B on week 2 of maintenance Regimen A Patients begin radiotherapy 5 days a week for 45 weeks to residual tumor on day 1 of maintenance Regimen B Patients receive whole brain irradiation 5 days a week for 31 weeks beginning on day 1 of maintenance Patients are followed monthly for 6 months every 3 months for 18 months every 6 months for 3 years and annually thereafter
PROJECTED ACCRUAL A total of 242 patients will be accrued for this study over approximately 54 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 |
|---|---|---|---|
| CDR0000063955 | OTHER | NCI | None |
| POG-9315 | OTHER | None | None |