Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165087
Status:
TERMINATED
Last Update Posted:
2007-12-28
First Post:
2005-09-09
Brief Title:
Treatment of Childhood Acute Lymphoblastic Leukemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Treatment of Childhood Acute Lymphoblastic Leukemia
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by IRB for continuing review
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to reduce the side-effects and discomfort of anti-leukemia therapy to attain long-term control of the disease and to hopefully eradicate it
Detailed Description:
Children with acute lymphoblastic leukemia ALL are treated somewhat differently depending upon on the relative risk of the leukemia recurring For this study they are classified into Standard Risk High Risk and InfantHigh Risk
The treatment for patients in the Standard Risk and High Risk groups consists of three phases of therapy induction treatment prevention of brain and spinal cord leukemia CNS treatment and intensificationcontinuation chemotherapy
The treatment for patients in the InfantHigh Risk group consists of four phases of therapy induction treatment infant intensification therapy intensificationcontinuation chemotherapy and CNS treatment
The induction treatment consists of a combination of chemotherapy drugs whose purpose is to kill all detectable leukemia cells This process usually requires a least one month and includes six anti-leukemia drugs These drugs are vincristine doxorubicin methotrexate cytosine arabinoside asparaginase and steroids methylprednisolone or prednisone
After the induction phase InfantHigh Risk patients will receive a highly intensive month of treatment infant intensification Drugs used during this month include high-dose methotrexate asparaginase 6-mercaptopurine and high dose cytosine arabinoside ARA-C
CNS treatment begins during induction therapy but is intensified during the second and third month after diagnosis Treatment for all patients will include a series of spinal taps with the instillation of anti-leukemia drugs including cytosine arabinoside and methotrexate and with or without hydrocortisone depending upon randomization
All high risk patients those in both High Risk and InfantHigh Risk as well as some standard risk patients will receive radiation treatment to the brain Radiation therapy will either be given in either conventional treatments once daily for 10 days or hyperfractionated treatments twice daily at half doses for 10 days Total dose of radiation is 1800 cGy
Intensification and continuation therapy begins 4-5 weeks after diagnosis for Standard Risk and High Risk groups and 4-5 weeks after infant intensification in InfantHigh Risk group This phase of treatment continues until the completion of two years of treatment Patients in the Standard Risk group will receive five anti-leukemia drugs vincristine prednisone methotrexate asparaginase and 6-mercaptopurine Patients in High Risk and InfantHigh Risk will receive six anti-leukemia drugs vincristine prednisone doxorubicin methotrexate asparaginase and 6-mercaptopurine
All patients will be able to participate in a randomization comparing two types of asparaginase Ecoli and Erwinia Patients will be randomized to receive either once weekly Ecoli or once-weekly Erwinia during the Intensification phase each given for a total of 20 weeks
Patients in the Standard Risk group are able to participate in an additional randomization Standard risk patients will be randomized to receive one of two different regimens designed to prevent central nervous system leukemia either 1radiation therapy given twice daily with chemotherapy in the spinal fluid every 18 weeks or 2 intensive chemotherapy in the spinal fluid alone without radiation
Patients in the High Risk and InfantHigh Risk groups are able to participate in two randomizations in addition to the asparaginase randomization The first will be to assess whether the drug dexrazoxane prevents heart damage caused by doxorubicin without affecting risk of relapse Patients will be randomized to receive either doxorubicin alone or doxorubicin with dexrazoxane during the induction CNS and intensification phases The second randomization will compare the relative efficacy and toxicity of different cranial radiation schedules Patients will be randomized to receive radiation in either once daily or twice daily fractions
Blood and bone marrow samples will be collected to learn more about the biology of leukemia These samples will also be used to test minimal residual disease levels to learn if these levels help predict risk of relapse
Quality of life questionnaires will also be performed by the parents of patients by children over eight and by the childs clinician
The treatment for patients in the Standard Risk and High Risk groups consists of three phases of therapy induction treatment prevention of brain and spinal cord leukemia CNS treatment and intensificationcontinuation chemotherapy
The treatment for patients in the InfantHigh Risk group consists of four phases of therapy induction treatment infant intensification therapy intensificationcontinuation chemotherapy and CNS treatment
The induction treatment consists of a combination of chemotherapy drugs whose purpose is to kill all detectable leukemia cells This process usually requires a least one month and includes six anti-leukemia drugs These drugs are vincristine doxorubicin methotrexate cytosine arabinoside asparaginase and steroids methylprednisolone or prednisone
After the induction phase InfantHigh Risk patients will receive a highly intensive month of treatment infant intensification Drugs used during this month include high-dose methotrexate asparaginase 6-mercaptopurine and high dose cytosine arabinoside ARA-C
CNS treatment begins during induction therapy but is intensified during the second and third month after diagnosis Treatment for all patients will include a series of spinal taps with the instillation of anti-leukemia drugs including cytosine arabinoside and methotrexate and with or without hydrocortisone depending upon randomization
All high risk patients those in both High Risk and InfantHigh Risk as well as some standard risk patients will receive radiation treatment to the brain Radiation therapy will either be given in either conventional treatments once daily for 10 days or hyperfractionated treatments twice daily at half doses for 10 days Total dose of radiation is 1800 cGy
Intensification and continuation therapy begins 4-5 weeks after diagnosis for Standard Risk and High Risk groups and 4-5 weeks after infant intensification in InfantHigh Risk group This phase of treatment continues until the completion of two years of treatment Patients in the Standard Risk group will receive five anti-leukemia drugs vincristine prednisone methotrexate asparaginase and 6-mercaptopurine Patients in High Risk and InfantHigh Risk will receive six anti-leukemia drugs vincristine prednisone doxorubicin methotrexate asparaginase and 6-mercaptopurine
All patients will be able to participate in a randomization comparing two types of asparaginase Ecoli and Erwinia Patients will be randomized to receive either once weekly Ecoli or once-weekly Erwinia during the Intensification phase each given for a total of 20 weeks
Patients in the Standard Risk group are able to participate in an additional randomization Standard risk patients will be randomized to receive one of two different regimens designed to prevent central nervous system leukemia either 1radiation therapy given twice daily with chemotherapy in the spinal fluid every 18 weeks or 2 intensive chemotherapy in the spinal fluid alone without radiation
Patients in the High Risk and InfantHigh Risk groups are able to participate in two randomizations in addition to the asparaginase randomization The first will be to assess whether the drug dexrazoxane prevents heart damage caused by doxorubicin without affecting risk of relapse Patients will be randomized to receive either doxorubicin alone or doxorubicin with dexrazoxane during the induction CNS and intensification phases The second randomization will compare the relative efficacy and toxicity of different cranial radiation schedules Patients will be randomized to receive radiation in either once daily or twice daily fractions
Blood and bone marrow samples will be collected to learn more about the biology of leukemia These samples will also be used to test minimal residual disease levels to learn if these levels help predict risk of relapse
Quality of life questionnaires will also be performed by the parents of patients by children over eight and by the childs clinician
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