Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia
This is a Phase I/II 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.
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.
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