Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019409
Status:
WITHDRAWN
Last Update Posted:
2012-03-23
First Post:
2001-07-11
Brief Title:
Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Study of Two Methods of CNS Prophylaxis in Patients With Acute Lymphoblastic Leukemia
Status:
WITHDRAWN
Status Verified Date:
2012-03
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 Radiation therapy uses high-energy x-rays to damage cancer cells Giving radiation therapy to the head or intrathecal chemotherapy may prevent cancer cells from spreading to the brain It is not yet known which treatment regimen is more effective for acute lymphoblastic leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the head or intrathecal chemotherapy plus high dose cytarabine in preventing CNS disease in children who have acute lymphoblastic leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the head or intrathecal chemotherapy plus high dose cytarabine in preventing CNS disease in children who have acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES I Compare the efficacy and toxicity of cranial radiation vs triple intrathecal chemotherapy plus high dose systemic cytarabine for prophylaxis of CNS disease in children with acute lymphoblastic leukemia II Compare the overall survival rates of these patients after these treatments
OUTLINE This is a randomized multicenter study for approved centers in India only All patients receive induction therapy and then are randomized to one of two treatment arms Patients assigned to arm I receive high dose cytarabine and no cranial radiation and patients assigned to arm II receive cranial radiation and no high dose cytarabine Induction 1 Patients receive vincristine IV on days 1 8 15 22 and 29 oral prednisone on days 1-28 triple intrathecal therapy methotrexate hydrocortisone and cytarabine TIT on days 1 8 15 and 22 asparaginase IM every other day on days 2-20 and daunorubicin IV on days 8 15 and 29 Patients who achieve remission proceed to randomization Arm I Induction 2 Patients receive oral mercaptopurine daily on days 1-7 and 22-28 cytarabine IV over 3 hours every 12 hours for 4 doses on days 1-2 and 22-23 cyclophosphamide IV on days 1 and 22 and TIT on days 8 and 29 Induction 1 is repeated then patients proceed to consolidation when blood counts have recovered sufficiently Consolidation Induction 2 is repeated then patients proceed to maintenance when blood counts have recovered sufficiently Maintenance 1 Patients receive vincristine IV and daunorubicin IV on day 1 oral prednisone on days 1-7 asparaginase IM on days 1 3 5 and 7 oral methotrexate once a week beginning on day 15 and skipping every 4th week for a total of 12 weeks oral mercaptopurine beginning on day 15 for 3 weeks out of 4 for a total of 12 weeks and TIT on days 1 and 36 Maintenance 2 Patients receive cytarabine IV over 3 hours every 12 hours for 4 doses on days 1-2 cyclophosphamide IV over 30 minutes on day 1 and methotrexate mercaptopurine and TIT on days 8 and 36 A total of 6 maintenance courses are administered alternating maintenance 1 and 2 Arm II Induction 2 Patients receive oral mercaptopurine daily on days 1-7 and 15-21 cyclophosphamide IV over 30 minutes on days 1 and 15 and intrathecal methotrexate on days 1 8 15 and 22 Patients then receive cranial radiation daily on days 4-12 Induction 1 is repeated then patients proceed to consolidation after blood counts have recovered sufficiently Consolidation Patients receive cyclophosphamide IV over 30 minutes on days 1-15 vincristine IV on days 1 and 15 oral mercaptopurine daily on days 1-7 and 15-21 and cytarabine subcutaneously every 12 hours for 6 doses on days 1-3 and 15-17 Patients proceed to maintenance when blood counts recover sufficiently Maintenance Same as maintenance 1 in arm I excluding TIT A total of 6 courses are administered All patients are followed monthly for the first 6 months then every other month for the next 6 months every 3 months for the next 2 years every 6 months for the next 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 1100 patients 550 per arm will be accrued for this study within 5 years
OUTLINE This is a randomized multicenter study for approved centers in India only All patients receive induction therapy and then are randomized to one of two treatment arms Patients assigned to arm I receive high dose cytarabine and no cranial radiation and patients assigned to arm II receive cranial radiation and no high dose cytarabine Induction 1 Patients receive vincristine IV on days 1 8 15 22 and 29 oral prednisone on days 1-28 triple intrathecal therapy methotrexate hydrocortisone and cytarabine TIT on days 1 8 15 and 22 asparaginase IM every other day on days 2-20 and daunorubicin IV on days 8 15 and 29 Patients who achieve remission proceed to randomization Arm I Induction 2 Patients receive oral mercaptopurine daily on days 1-7 and 22-28 cytarabine IV over 3 hours every 12 hours for 4 doses on days 1-2 and 22-23 cyclophosphamide IV on days 1 and 22 and TIT on days 8 and 29 Induction 1 is repeated then patients proceed to consolidation when blood counts have recovered sufficiently Consolidation Induction 2 is repeated then patients proceed to maintenance when blood counts have recovered sufficiently Maintenance 1 Patients receive vincristine IV and daunorubicin IV on day 1 oral prednisone on days 1-7 asparaginase IM on days 1 3 5 and 7 oral methotrexate once a week beginning on day 15 and skipping every 4th week for a total of 12 weeks oral mercaptopurine beginning on day 15 for 3 weeks out of 4 for a total of 12 weeks and TIT on days 1 and 36 Maintenance 2 Patients receive cytarabine IV over 3 hours every 12 hours for 4 doses on days 1-2 cyclophosphamide IV over 30 minutes on day 1 and methotrexate mercaptopurine and TIT on days 8 and 36 A total of 6 maintenance courses are administered alternating maintenance 1 and 2 Arm II Induction 2 Patients receive oral mercaptopurine daily on days 1-7 and 15-21 cyclophosphamide IV over 30 minutes on days 1 and 15 and intrathecal methotrexate on days 1 8 15 and 22 Patients then receive cranial radiation daily on days 4-12 Induction 1 is repeated then patients proceed to consolidation after blood counts have recovered sufficiently Consolidation Patients receive cyclophosphamide IV over 30 minutes on days 1-15 vincristine IV on days 1 and 15 oral mercaptopurine daily on days 1-7 and 15-21 and cytarabine subcutaneously every 12 hours for 6 doses on days 1-3 and 15-17 Patients proceed to maintenance when blood counts recover sufficiently Maintenance Same as maintenance 1 in arm I excluding TIT A total of 6 courses are administered All patients are followed monthly for the first 6 months then every other month for the next 6 months every 3 months for the next 2 years every 6 months for the next 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 1100 patients 550 per arm will be accrued for this study within 5 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 |
|---|---|---|---|
| 98-C-N007 | None | None | None |
| MCP943 | None | None | None |
| NCI-0H98-C-N007 | None | None | None |
| CDR0000066120 | None | None | None |