A Phase I Study of Bexarotene in Patients With Acute Myeloid Leukemia
Despite recent advances in cancer treatment, the prognosis is still poor for patients with
relapsed or chemotherapy resistant AML. Further aggressive chemotherapy can be attempted,
but generally yields poor results. This clinical study is the first use of bexarotene in
the treatment of patient with relapsed or chemotherapy resistant AML. The main purpose of
the study is to identify the maximum safe dose of bexarotene in patient with AML. Another
objective of the study is to explore the side effect profile of bexarotene in AML patients.
The study is organized so that the initial patients will get a low dose of bexarotene to be
taken daily. If these patients tolerate the drug, then later patients will get higher daily
doses. Further groups of patients will continue to increase their dose of bexarotene until
a maximum tolerated dose is identified. The stu dy will end at that point. Patients will
take the drug daily by mouth until such a time that their AML is worsening or they are
experiencing unacceptable side effects. Their participating will end at that point.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To identify the maximum tolerated daily dose of bexarotene in patients with Acute Myeloid Leukemia
Donald E Tsai, M.D., Ph.D.
University of Pennsylvania
United States: Institutional Review Board
|Abramson Cancer Center Of University of Pennsylvania||Philadelphia, Pennsylvania 19104|