Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440726
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2007-02-23
Brief Title:
Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia ALL
Sponsor:
Therapeutic Advances in Childhood Leukemia Consortium
Organization:
Therapeutic Advances in Childhood Leukemia Consortium
Study Overview
Official Title:
A Study of Bortezomib With Chemotherapy for RelapsedRefractory Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2020-02
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 Phase III study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia ALL that has come back recurred Bortezomib is a drug that has been approved by the Food and Drug Administration FDA for treating adults with multiple myeloma which is a type of blood cancer Bortezomib has been shown to cause cancer cells to die in studies done on animals mice Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs
Detailed Description:
All patients will receive 1 course of chemotherapy unless medical complications prevent the administration of some of the drugs Treatment will last about 1 month
Treatment on this study will consist of a combination of 7 anti-cancer medications The 7 anti-cancer medicines are bortezomib vincristine dexamethasone PEG-asparaginase doxorubicin cytarabine Ara-C and methotrexate MTX
If you are in the Phase I portion of this study you will be given an assigned dose of bortezomib The dose of bortezomib will be based on doses given in previous studies done with adults and children At each dose level of bortezomib between 3 and 6 children will receive bortezomib in combination with chemotherapy If the side effects are not too severe the next group of children will receive a higher dose The dose will continue to be increased until we find the dose that causes serious side effects Your dose of bortezomib will not be increased If you have bad side effects your dose may be decreased
The dose used during the Phase 2 part of this study will be determined by the outcome of the Phase I study The highest dose used in Phase I that was tolerated without serious side effects will be the one used in Phase 2
Treatment on this study will consist of a combination of 7 anti-cancer medications The 7 anti-cancer medicines are bortezomib vincristine dexamethasone PEG-asparaginase doxorubicin cytarabine Ara-C and methotrexate MTX
If you are in the Phase I portion of this study you will be given an assigned dose of bortezomib The dose of bortezomib will be based on doses given in previous studies done with adults and children At each dose level of bortezomib between 3 and 6 children will receive bortezomib in combination with chemotherapy If the side effects are not too severe the next group of children will receive a higher dose The dose will continue to be increased until we find the dose that causes serious side effects Your dose of bortezomib will not be increased If you have bad side effects your dose may be decreased
The dose used during the Phase 2 part of this study will be determined by the outcome of the Phase I study The highest dose used in Phase I that was tolerated without serious side effects will be the one used in Phase 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None