Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)



Status:Archived
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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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.

The Phase I portion of this study is complete and the dose for the phase II portion of the
study is 1.3mg/m2/day. The phase II portion of the study is open and accruing.


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.


We found this trial at
10
sites
Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
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300 Longwood Avenue
Boston, Massachusetts 02115
617-355-6000
Children's Hospital - Boston Boston Children's Hospital is a 395-bed comprehensive center for pediatric health...
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Boston, MA
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
University of Miami Hospital The University of Miami changed the face of modern health care...
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Miami, FL
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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Stanford, California 94305
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Stanford, CA
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