Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
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|ClinicalTrials.gov Identifier: NCT00440726|
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : July 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: bortezomib (Velcade) Drug: dexamethasone Drug: PEG-asparaginase Drug: doxorubicin Drug: cytarabine Drug: methotrexate Drug: vincristine||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2011|
- Drug: bortezomib (Velcade)
Intravenous at 1.3mg/m2 on days 1, 4, 8 and 11Other Name: Velcade
- Drug: dexamethasone
Intravenous or oral administration for 14 days.
- Drug: PEG-asparaginase
- Drug: doxorubicin
- Drug: cytarabine
Intrathecal administration on day 1
- Drug: methotrexate
- Drug: vincristine
Intravenous push on days 1, 8, 15, 22
- Dose limiting toxicity [ Time Frame: Each dose level is evaluated ]
- Maximum tolerated dose [ Time Frame: Each dose level is evaluated ]
- Rate of remission [ Time Frame: The rate of remission will be evaluated upon completion of the phase I portion and then the phase II portion. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440726
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Childrens Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94304-1812|
|UCSF School of Medicine|
|San Francisco, California, United States, 94143-0106|
|United States, Florida|
|University of Miami Cancer Center|
|Miami, Florida, United States, 33136|
|United States, Michigan|
|C.S. Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109-0914|
|United States, Minnesota|
|Childrens Hospital & Clinics of Minnesota|
|Minneapolis, Minnesota, United States, 55404-4597|
|United States, New York|
|New York University Medical Center|
|New York, New York, United States, 10016|
|Children's Hospital New York-Presbyterian|
|New York, New York, United States, 10032|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Study Chair:||Yoav Messinger, MD||Children's Hospital and Clinics of Minnesota|