Spots Global Cancer Trial Database for Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
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Trial Identification
Brief Title: Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
Official Title: A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia
Study ID: NCT00440726
Conditions
Study Description
Brief Summary: 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.
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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Miller Children's Hospital, Long Beach, California, United States
Childrens Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital & Research Center Oakland, Oakland, California, United States
Stanford University Medical Center, Palo Alto, California, United States
UCSF School of Medicine, San Francisco, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Miami Cancer Center, Miami, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Johns Hopkins / Sydney Kimmel Cancer Center, Baltimore, Maryland, United States
Dana Farber Cancer Center, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Childrens Hospital & Clinics of Minnesota, Minneapolis, Minnesota, United States
New York University Medical Center, New York, New York, United States
Children's Hospital New York-Presbyterian, New York, New York, United States
Levine Children's Hospital, Charlotte, North Carolina, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
Universidade Federale de Sao Paulo/Hospital Sao Paulo, São Paulo, , Brazil
Sick Kids, Toronto, Ontario, Canada
Contact Details
Name: Yoav Messinger, MD
Affiliation: Children's Hospital and Clinics of Minnesota
Role: STUDY_CHAIR
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