Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187070
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2005-09-12
Brief Title:
Large Cell Lymphoma Pilot Study III
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Large Cell Lymphoma Pilot Study III
Status:
COMPLETED
Status Verified Date:
2008-05
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:
The main purpose of this study is to find out if it is feasible to deliver a multi-agent chemotherapy regimen which features a shorter more intensive immunophenotype-directed approach and includes an intensification phase with hematopoietic stem cell support for children with large cell lymphoma
Detailed Description:
Secondary objectives will include documenting the toxicity associated with the treatment regimen and to estimate the response rates and survival of participants with large cell lymphoma treated on this protocol
Patients will be treated with induction consolidation and maintenance treatment
Induction
MIED chemotherapy - High dose methotrexate ifosfamide etoposide and dexamethasone for 2 cycles
High-dose methotrexate 8 gmm2 on Day 1 with leucovorin rescue Ifosfamide 2 gmm2day on days 2-4 total of 3 days Etoposide VP-16 200 mgm2day on Days 2-4 total of 3 days Dexamethasone 40 mgm2day IV on days 1-4 given IV or PO daily x 4 Intrathecal MHA age adjusted dosages
Consolidation
COPADM chemotherapy for 2 cycles - cyclophosphamide vincristine prednisone adriamycin high-dose methotrexate
COPAM1 High dose methotrexate HD MTX 5 gmm2 IV over 4 hours on Day 1 with leucovorin rescue Doxorubicin 60 mgm2 IV over 6 hours on Day 2 Vincristine 20 mgm2 20 mg max Day 1 Cyclophosphamide 500 mgm2day divided every 12 hours Days 2-4 Prednisone 60 mgm2 divided bid Days 1-5 Intrathecal MHA age adjusted dosages
COPADM2 - like COPADM1 except 1 cyclophosphamide dose increased to 1 gmm2day divided every 12 hours on Days 2-4 and 2 second dose of vincristine given on Day 6
DAC chemotherapy x 1 cycle - Dexamethasone cytarabine and carboplatin
Carboplatin AUC of 8 Day 1 Ara-C 2 gmm2dose q12 x 2 Day 2 Dexamethasone 40 mgm2day Days 1-4 ITMHA dose age adjusted
Hematopoietic Stem Cell Transplantation - high-dose cyclophosphamide and etoposide
Involved field radiation to the primary tumor will be given over 3-4 weeks Participants with CNS disease at diagnosis will also receive cranial irradiation
Maintenance chemotherapy
Vinblastine 6 mgm2 IV weekly for one year
Patients will be treated with induction consolidation and maintenance treatment
Induction
MIED chemotherapy - High dose methotrexate ifosfamide etoposide and dexamethasone for 2 cycles
High-dose methotrexate 8 gmm2 on Day 1 with leucovorin rescue Ifosfamide 2 gmm2day on days 2-4 total of 3 days Etoposide VP-16 200 mgm2day on Days 2-4 total of 3 days Dexamethasone 40 mgm2day IV on days 1-4 given IV or PO daily x 4 Intrathecal MHA age adjusted dosages
Consolidation
COPADM chemotherapy for 2 cycles - cyclophosphamide vincristine prednisone adriamycin high-dose methotrexate
COPAM1 High dose methotrexate HD MTX 5 gmm2 IV over 4 hours on Day 1 with leucovorin rescue Doxorubicin 60 mgm2 IV over 6 hours on Day 2 Vincristine 20 mgm2 20 mg max Day 1 Cyclophosphamide 500 mgm2day divided every 12 hours Days 2-4 Prednisone 60 mgm2 divided bid Days 1-5 Intrathecal MHA age adjusted dosages
COPADM2 - like COPADM1 except 1 cyclophosphamide dose increased to 1 gmm2day divided every 12 hours on Days 2-4 and 2 second dose of vincristine given on Day 6
DAC chemotherapy x 1 cycle - Dexamethasone cytarabine and carboplatin
Carboplatin AUC of 8 Day 1 Ara-C 2 gmm2dose q12 x 2 Day 2 Dexamethasone 40 mgm2day Days 1-4 ITMHA dose age adjusted
Hematopoietic Stem Cell Transplantation - high-dose cyclophosphamide and etoposide
Involved field radiation to the primary tumor will be given over 3-4 weeks Participants with CNS disease at diagnosis will also receive cranial irradiation
Maintenance chemotherapy
Vinblastine 6 mgm2 IV weekly for one year
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