Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187161
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2005-09-13
Brief Title:
Treatment of Burkitt LymphomaLeukemia and B Large Cell NHL
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Small Noncleaved Cell SNCC Non-Hodgkin Lymphoma NHL Large Cell NHL B-Cell and B-Cell Acute Lymphoblastic Leukemia B-ALL Study II
Status:
COMPLETED
Status Verified Date:
2008-06
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 is a pilot study to demonstrate that the modified LMB-89 treatment regimen for children with newly diagnosed small noncleaved cell NHL large cell NHL B-cell and B-cell acute lymphoblastic leukemia can be delivered in this setting with acceptable toxicity
Detailed Description:
Group A Resected Stage I and resected abdominal Stage II
Subjects will receive two courses 3 weeks apart of COPAD as follows
Cyclophosphamide CTX 500 mgm2day divided q12 hrs IV day 1 2 3 Vincristine VCR 2 mgm2 max 20 mg IV day 1 6 Prednisone 60 mgm2d divided bid PO day 1-5 Adriamycin 60 mgm2 over 6 hrs IV day 1 GCSF 5 mcgkgday SQ will be given once a day starting on day 7 until blood counts recover
Group B Other Stage II Stage III Stage IV or B-ALL M blast 70 no CNS involvement
Treatment Pre-Induction
Subjects in Group B will receive one week of treatment of COP as follows
CTX 300 mgm2 IV day 1 VCR 1 mgm2 max 20 mg IV day 1 Prednisone 60 mgm2day divided bid PO day 1-7 Methotrexate MTX and hydrocortisone HC into the spinal fluid IT each age adjusted day 1 Induction -COPADM x 2 COPAD M3 1 starting day 8 COP if greater than or equal to 20 reduction in tumor size by day 7 COP if 20 then proceed to Group C starting at COPADM8 No 1 COPADM3 1 VCR 2 mgm2 max 2 mg IV day 1 High-dose HD MTX 3 gmm2 IV over 3 hrs day 1 MTX and HC each age adjusted IT day 2 6 CTX 500 mgm2day divided q12 hrs IV day 2 3 4 Adriamycin 60 mgm2 over 6 hrs IV day 2 Prednisone 60 mgm2 divided bid po day 1-5 G-CSF 5 mcgkgday starting day 7 until counts recover
COPADM3 2
Like COPADM 1 above except
1 CTX - double dose 1 gmm2day divided q12 hr
2 VCR - second dose given on day 6 Consolidation- CYM x 2 courses HDMTX 3 gmm2 over 3 hr IV Day 1 MTX plus HC each age adjusted IT day 2 Cytarabine Ara-C 100 mgm2day CIIV x 5 days day 2-6 Ara-C and HC each age adjusted IT day 7
Maintenance Sequence 1 Prednisone 60 mgm2d divided bid PO day 1-5 HDMTX 3 gmm2 over 3 hr IV Day 1 MTX plus HC each age adjusted IT day 2 CTX 500 mgm2day IV day 2 3 Adriamycin 60 mgm2 over 6 hrs IV day 3 VCR 2 mgm2 max 2 mg IV day 1 G-CSF 5 mcgkgday starting day 6 until counts recover
Group C B-ALL with 70 BM blasts CNS involvement Group B COP failures ie 20 reduction Treatment Pre-Induction
Subjects will receive one week of treatment of COP as follows
CTX 300 mgm2 IV day 1 VCR 1 mgm2 max 2 mg IV day 1 Prednisone 60 mgm2d divided bid po day 1-7 MTX HC Ara-C each age adjusted IT day 1 3 5 Leucovorin 15 mgm2 q12 hr x 2 po day 2 4 Induction-COPADM x 2
Subjects will begin induction therapy the day after COP is finished as follows
COPADM81 VCR 2 mgm2 max 2 mg IV day 1 HD MTX 8 gmm2 over 4 hrs IV Day 1 MTXHCAra-C each age adjusted IT day 1 4 6 Ommaya day 1 CTX 500 mgm2day divided every 12 hours IV day 2 3 4 Adriamycin 60 mgm2 over 6 hrs IV day 2 Prednisone 60 mgm2day divided bid poIV day 1-5 G-CSF 5 mcgkgday starting day 7 until counts recover
COPADM8 2
Like COPAD M8 1 except
1 CTX-double dose 1 gmm2day divided q12hs IV
2 VCR - 2nd dose given on day 6 Consolidation - CYVE x 2 courses Ara-C 50 mgm212 hrs CIIV Day 1-5 HD Ara-C 3 gmm2day IV over 3 hours Day 2-5 VP-16 200 mgm2day IV over 2 hours Day 2-5
Maintenance Subjects will receive four courses of chemotherapy during continuation Each course will use different chemotherapy drugs
Sequence 1 Prednisone 60 mgm2day divided bid poIV day 1-5 HD MTX 8 gmm2 over 4 hrs IV Day 1 MTXHCAra-C each age adjusted IT day 2 Ommaya day 2 CTX 500 mgm2 IV day 2 3 Adriamycin 60 mgm2 over 6 hrs IV day 3 VCR 2 mgm2 max 2 mg IV day 1 G-CSF 5 mcgkgday starting day 7 until counts recover
Sequence 2 Ara-C 100 mgm2day divided q12 hrs SQ Day 1-5 VP-16 150 mgm2day over 2 hrs IV Days 1-3 G-CSF 5 micro gkg SQ Days 6 until counts recovery MTXHCAra-C each age adjusted IT Day 1 CNS positive only Ommaya Day 1 CNS positive only Sequence 3 Prednisone 60 mgm2day divided bid po day 1-5 CTX 500 mgm2day IV day 1 2 Adriamycin 60 mgm2 over 6 hrs IV day 2 VCR 2 mgm2 max 2 mg IV day 1 G-CSF 5 mcgkg SQ starting day 6 until counts recover MTXHCAra-C each age adjusted IT Day 1 CNS positive only Ommaya Day 1 CNS positive only
Sequence 4 Ara-C 100 mgm2day divided q12 hrs SQ Day 1-5 VP-16 150 mgm2day over 2 hrs IV Days 1-3 G-CSF 5 mcgkg SQ days 6 until counts recover MTXHCAra-C each age adjusted IT Day 1 CNS positive only Ommaya Day 1 CNS positive only
Intrathecal IT Treatment doses and volume are as follows
than 1 year MTX 8 mg HC 8 mg Ara C 15 mg Volume 8 ml Age 12-23 mo MTX 10 mg HC 10 mg Ara C 20 mg Volume 10 ml Age 24-35 mo MTX 12 mg HC 12 mg Ara C 25 mg Volume 12 ml Age 3 yr MTX 15 mg HC 15 mg Ara C 30 mg Volume 15 ml Ommaya Reservoir Treatment CNS positive only Age 3 yr MTX 6 mg HC 15 mg Ara C 50 mgm2 50 mg max Volume 3 ml
Subjects will receive two courses 3 weeks apart of COPAD as follows
Cyclophosphamide CTX 500 mgm2day divided q12 hrs IV day 1 2 3 Vincristine VCR 2 mgm2 max 20 mg IV day 1 6 Prednisone 60 mgm2d divided bid PO day 1-5 Adriamycin 60 mgm2 over 6 hrs IV day 1 GCSF 5 mcgkgday SQ will be given once a day starting on day 7 until blood counts recover
Group B Other Stage II Stage III Stage IV or B-ALL M blast 70 no CNS involvement
Treatment Pre-Induction
Subjects in Group B will receive one week of treatment of COP as follows
CTX 300 mgm2 IV day 1 VCR 1 mgm2 max 20 mg IV day 1 Prednisone 60 mgm2day divided bid PO day 1-7 Methotrexate MTX and hydrocortisone HC into the spinal fluid IT each age adjusted day 1 Induction -COPADM x 2 COPAD M3 1 starting day 8 COP if greater than or equal to 20 reduction in tumor size by day 7 COP if 20 then proceed to Group C starting at COPADM8 No 1 COPADM3 1 VCR 2 mgm2 max 2 mg IV day 1 High-dose HD MTX 3 gmm2 IV over 3 hrs day 1 MTX and HC each age adjusted IT day 2 6 CTX 500 mgm2day divided q12 hrs IV day 2 3 4 Adriamycin 60 mgm2 over 6 hrs IV day 2 Prednisone 60 mgm2 divided bid po day 1-5 G-CSF 5 mcgkgday starting day 7 until counts recover
COPADM3 2
Like COPADM 1 above except
1 CTX - double dose 1 gmm2day divided q12 hr
2 VCR - second dose given on day 6 Consolidation- CYM x 2 courses HDMTX 3 gmm2 over 3 hr IV Day 1 MTX plus HC each age adjusted IT day 2 Cytarabine Ara-C 100 mgm2day CIIV x 5 days day 2-6 Ara-C and HC each age adjusted IT day 7
Maintenance Sequence 1 Prednisone 60 mgm2d divided bid PO day 1-5 HDMTX 3 gmm2 over 3 hr IV Day 1 MTX plus HC each age adjusted IT day 2 CTX 500 mgm2day IV day 2 3 Adriamycin 60 mgm2 over 6 hrs IV day 3 VCR 2 mgm2 max 2 mg IV day 1 G-CSF 5 mcgkgday starting day 6 until counts recover
Group C B-ALL with 70 BM blasts CNS involvement Group B COP failures ie 20 reduction Treatment Pre-Induction
Subjects will receive one week of treatment of COP as follows
CTX 300 mgm2 IV day 1 VCR 1 mgm2 max 2 mg IV day 1 Prednisone 60 mgm2d divided bid po day 1-7 MTX HC Ara-C each age adjusted IT day 1 3 5 Leucovorin 15 mgm2 q12 hr x 2 po day 2 4 Induction-COPADM x 2
Subjects will begin induction therapy the day after COP is finished as follows
COPADM81 VCR 2 mgm2 max 2 mg IV day 1 HD MTX 8 gmm2 over 4 hrs IV Day 1 MTXHCAra-C each age adjusted IT day 1 4 6 Ommaya day 1 CTX 500 mgm2day divided every 12 hours IV day 2 3 4 Adriamycin 60 mgm2 over 6 hrs IV day 2 Prednisone 60 mgm2day divided bid poIV day 1-5 G-CSF 5 mcgkgday starting day 7 until counts recover
COPADM8 2
Like COPAD M8 1 except
1 CTX-double dose 1 gmm2day divided q12hs IV
2 VCR - 2nd dose given on day 6 Consolidation - CYVE x 2 courses Ara-C 50 mgm212 hrs CIIV Day 1-5 HD Ara-C 3 gmm2day IV over 3 hours Day 2-5 VP-16 200 mgm2day IV over 2 hours Day 2-5
Maintenance Subjects will receive four courses of chemotherapy during continuation Each course will use different chemotherapy drugs
Sequence 1 Prednisone 60 mgm2day divided bid poIV day 1-5 HD MTX 8 gmm2 over 4 hrs IV Day 1 MTXHCAra-C each age adjusted IT day 2 Ommaya day 2 CTX 500 mgm2 IV day 2 3 Adriamycin 60 mgm2 over 6 hrs IV day 3 VCR 2 mgm2 max 2 mg IV day 1 G-CSF 5 mcgkgday starting day 7 until counts recover
Sequence 2 Ara-C 100 mgm2day divided q12 hrs SQ Day 1-5 VP-16 150 mgm2day over 2 hrs IV Days 1-3 G-CSF 5 micro gkg SQ Days 6 until counts recovery MTXHCAra-C each age adjusted IT Day 1 CNS positive only Ommaya Day 1 CNS positive only Sequence 3 Prednisone 60 mgm2day divided bid po day 1-5 CTX 500 mgm2day IV day 1 2 Adriamycin 60 mgm2 over 6 hrs IV day 2 VCR 2 mgm2 max 2 mg IV day 1 G-CSF 5 mcgkg SQ starting day 6 until counts recover MTXHCAra-C each age adjusted IT Day 1 CNS positive only Ommaya Day 1 CNS positive only
Sequence 4 Ara-C 100 mgm2day divided q12 hrs SQ Day 1-5 VP-16 150 mgm2day over 2 hrs IV Days 1-3 G-CSF 5 mcgkg SQ days 6 until counts recover MTXHCAra-C each age adjusted IT Day 1 CNS positive only Ommaya Day 1 CNS positive only
Intrathecal IT Treatment doses and volume are as follows
than 1 year MTX 8 mg HC 8 mg Ara C 15 mg Volume 8 ml Age 12-23 mo MTX 10 mg HC 10 mg Ara C 20 mg Volume 10 ml Age 24-35 mo MTX 12 mg HC 12 mg Ara C 25 mg Volume 12 ml Age 3 yr MTX 15 mg HC 15 mg Ara C 30 mg Volume 15 ml Ommaya Reservoir Treatment CNS positive only Age 3 yr MTX 6 mg HC 15 mg Ara C 50 mgm2 50 mg max Volume 3 ml
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