Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003783
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Very High Risk Acute Lymphocytic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
ALinC 17 Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia ALL A Pediatric Oncology Group Pilot Study
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 Combining more than one drug and combining drugs in different ways may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of chemotherapy in treating children who have very high risk acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the feasibility of administering a new combination of agents during postinduction consolidation therapy in children with very high risk acute lymphocytic leukemia VHR-ALL II Assess the tolerance of patients in remission of VHR-ALL for postconsolidation therapy with continuous intensification
OUTLINE Patients receive induction therapy on weeks 1-4 This consists of oral prednisone three times a day on days 1-28 vincristine IV on days 1 8 15 and 22 daunorubicin IV on days 8 15 and 22 and asparaginase IM on days 2 5 8 12 15 and 19 Patients also receive methotrexate intrathecally IT on days 1 and 8 Patients with CNS 2 and 3 disease also receive methotrexate IT on days 15 and 22 Patients who achieve M2 bone marrow on day 29 receive oral prednisone three times a day on days 29-42 vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36 and asparaginase IM on days 29 32 36 and 39 If bone marrow is M3 on day 29 or M2 or M3 on day 43 then patient is off study Patients proceed to consolidation therapy on weeks 5-25 This consists of high dose methotrexate IV over 24 hours on weeks 6 8 16 and 18 followed by leucovorin calcium IV or orally every 6 hours for 5 doses oral mercaptopurine on weeks 6-9 and 16-19 cytarabine IV over 6 hours followed by idarubicin IV over 15 minutes for 4 days and filgrastim G-CSF subcutaneously SQ beginning on day 5 and continuing for about 10-14 days on weeks 10 and 20 Patients receive etoposide IV over 1 hour followed by cyclophosphamide IV over 10 minutes for 5 days and G-CSF SQ beginning on day 6 for 10-14 days on weeks 13 and 23 Methotrexate IT is administered on weeks 6 8 13 16 18 and 23 Patients then proceed to continuous intensification therapy during weeks 26-61 Patients receive vincristine IV daunorubicin IV and methotrexate IT on day 1 and oral dexamethasone twice a day on days 1-7 on weeks 26 32 38 44 50 and 56 Patients also receive high dose cytarabine IV over 1 hour every 12 hours for 4 doses followed by asparaginase IM 3 hours after the last dose of cytarabine on weeks 27 33 39 45 51 and 57 Oral mercaptopurine and methotrexate IM are administered on day 1 during weeks 29 31 35 37 41 43 47 49 53 55 59 and 61 Patients receive etoposide IV over 1-2 hours followed by cyclophosphamide IV during weeks 30 36 42 48 54 and 60 Patients then proceed to continuation therapy during weeks 62-126 Vincristine IV and cyclophosphamide IV are administered on weeks 62-65 70-73 78-81 86-89 94-97 102-105 110-113 and 118-121 Patients also receive oral dexamethasone twice a day for 7 days on weeks 62 70 78 86 94 102 110 and 118 and cytarabine IV on weeks 63 65 71 73 79 81 87 89 95 97 103 105 111 113 119 and 121 Oral mercaptopurine is administered daily during weeks 66-69 74-77 82-85 90-93 98-101 106-109 114-117 and 122-125 and methotrexate IM on weeks 66-69 74-77 82-85 90-93 98-101 106-109 114-117 and 122-125 Methotrexate IT is administered during weeks 62 70 78 86 94 102 110 and 118 Patients who are CNS 3 at diagnosis receive whole brain irradiation beginning at week 62 along with the first course of continuation therapy These patients do not receive any methotrexate IT after week 62 Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year every 6 months for 1 year then annually thereafter
PROJECTED ACCRUAL A total of 38 patients will be accrued for this study within 12 months
OUTLINE Patients receive induction therapy on weeks 1-4 This consists of oral prednisone three times a day on days 1-28 vincristine IV on days 1 8 15 and 22 daunorubicin IV on days 8 15 and 22 and asparaginase IM on days 2 5 8 12 15 and 19 Patients also receive methotrexate intrathecally IT on days 1 and 8 Patients with CNS 2 and 3 disease also receive methotrexate IT on days 15 and 22 Patients who achieve M2 bone marrow on day 29 receive oral prednisone three times a day on days 29-42 vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36 and asparaginase IM on days 29 32 36 and 39 If bone marrow is M3 on day 29 or M2 or M3 on day 43 then patient is off study Patients proceed to consolidation therapy on weeks 5-25 This consists of high dose methotrexate IV over 24 hours on weeks 6 8 16 and 18 followed by leucovorin calcium IV or orally every 6 hours for 5 doses oral mercaptopurine on weeks 6-9 and 16-19 cytarabine IV over 6 hours followed by idarubicin IV over 15 minutes for 4 days and filgrastim G-CSF subcutaneously SQ beginning on day 5 and continuing for about 10-14 days on weeks 10 and 20 Patients receive etoposide IV over 1 hour followed by cyclophosphamide IV over 10 minutes for 5 days and G-CSF SQ beginning on day 6 for 10-14 days on weeks 13 and 23 Methotrexate IT is administered on weeks 6 8 13 16 18 and 23 Patients then proceed to continuous intensification therapy during weeks 26-61 Patients receive vincristine IV daunorubicin IV and methotrexate IT on day 1 and oral dexamethasone twice a day on days 1-7 on weeks 26 32 38 44 50 and 56 Patients also receive high dose cytarabine IV over 1 hour every 12 hours for 4 doses followed by asparaginase IM 3 hours after the last dose of cytarabine on weeks 27 33 39 45 51 and 57 Oral mercaptopurine and methotrexate IM are administered on day 1 during weeks 29 31 35 37 41 43 47 49 53 55 59 and 61 Patients receive etoposide IV over 1-2 hours followed by cyclophosphamide IV during weeks 30 36 42 48 54 and 60 Patients then proceed to continuation therapy during weeks 62-126 Vincristine IV and cyclophosphamide IV are administered on weeks 62-65 70-73 78-81 86-89 94-97 102-105 110-113 and 118-121 Patients also receive oral dexamethasone twice a day for 7 days on weeks 62 70 78 86 94 102 110 and 118 and cytarabine IV on weeks 63 65 71 73 79 81 87 89 95 97 103 105 111 113 119 and 121 Oral mercaptopurine is administered daily during weeks 66-69 74-77 82-85 90-93 98-101 106-109 114-117 and 122-125 and methotrexate IM on weeks 66-69 74-77 82-85 90-93 98-101 106-109 114-117 and 122-125 Methotrexate IT is administered during weeks 62 70 78 86 94 102 110 and 118 Patients who are CNS 3 at diagnosis receive whole brain irradiation beginning at week 62 along with the first course of continuation therapy These patients do not receive any methotrexate IT after week 62 Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year every 6 months for 1 year then annually thereafter
PROJECTED ACCRUAL A total of 38 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| CDR0000066915 | OTHER | NCI | None |
| POG-9806 | OTHER | None | None |