Acute Myeloid Leukemia Bortezomib Study – Phase II Pilot

Bortezomib Combined with Reinduction Chemotherapy in Children and Young Adults with Recurrent, Refractory or Secondary Acute Myeloid Leukemia

Protocol Description

This Children’s Oncology Group Phase II Pilot study investigates the use of the anti-cancer drug bortezomib in combination with a standard chemotherapy for treating younger patients with acute myeloid leukemia (AML) that has not responded to standard treatment (refractory) or has come back (recurrent or relapsed). Refractory and relapsed AML are usually treated with chemotherapy such as cytarabine, etoposide or idarubicin. There are two parts to this study, which is intended to determine efficacy and tolerance levels of the experimental treatments.

Study Level: Phase II Pilot

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from age 1 to 21, who have been diagnosed with AML that has relapsed, is refractory or has developed after treatment for a different type of cancer (secondary).
Males: Ages 1 to 21
Females: Ages 1 to 21

For the Group 1 “efficacy” phase, patients receive low-dose cytarabine, idarubicin and bortezomib (CIB) intravenously over a course of eight days, with treatment repeated every 28 days for up to 2 courses. For the Group 2 “dose-finding and efficacy” phase, patients receive high-dose cytarabine, etoposide and bortezomib (CEB) over a course of 8 days, with treatment repeated every 28 days for up to 2 courses.
Visits: Requires admittance for treatments
Duration: Up to 56 days

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study AAML07P1)
National Cancer Institute
Millennium Pharmaceuticals

Additional Resources
Children's Oncology Group CureSearch
Study Description at National Institutes of Health

Primary Investigator(s)

Rakesh Goyal, MD

Contact Information

To get started, please contact:
Jill Visnich, CRA

Last Update
February 17, 2014
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Last Update
February 17, 2014