OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT)
II. Measure the blood pharmacokinetics of LEM following IV administration.
III. Observe any anti-tumor effects of LEM.
PROTOCOL OUTLINE: This is an open-label study for patients with advanced and/or metastatic,
histologically-documented solid tumors considered to be unresponsive to available
LEM will be administered IV over 45 minutes. At least three patients will be studied at
each dose level and at least three patients will complete one 21-day course before any
patient is enrolled at the next dose level. Study drug administration will continue on an
every 3-week schedule in the absence of progressive disease or unacceptable toxicity. A
subsequent course of treatment may be administered at least 21 days after a prior LEM dose
has been administered when study criteria are met.
Cohorts of 3 patients per dose level will be studied. This will be expanded to 6 if a DLT
occurs, followed by a total of 6 patients at a possible MTD.
PROJECTED ACCRUAL: It is expected that 21 to 30 patients will be entered into the study to
determine the MTD: 3 per dose level, expanded to 6 if DLT occurs, followed by a total of 6
patients at a possible MTD. The dose level identified as the MTD may then be expanded up to
12 patients to permit additional safety assessment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Przemyslaw Twardowski, M.D.
City of Hope National Medical Center
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|City of Hope National Medical Center||Los Angeles, California 91010|
|The Ohio State University||Columbus, Ohio 43210|