A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia
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.
This is an abbreviated list.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose limiting toxicity
Each dose level is evaluated
Yoav Messinger, MD
Children's Hospital and Clinics of Minnesota
United States: Institutional Review Board
|Stanford University Medical Center||Stanford, California 94305-5408|
|Childrens Hospital Los Angeles||Los Angeles, California 90027|
|City of Hope||Duarte, California 91010|
|New York University Medical Center||New York, New York 10016|
|Seattle Children's Hospital||Seattle, Washington 98105|
|UCSF School of Medicine||San Francisco, California 94143-0106|
|University of Miami Cancer Center||Miami, Florida 33136|
|C.S. Mott Children's Hospital||Ann Arbor, Michigan 48109-0914|
|Childrens Hospital & Clinics of Minnesota||Minneapolis, Minnesota 55404-4597|
|Children's Hospital New York-Presbyterian||New York, New York 10032|