This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be administered at 14-day intervals.
This open label study consists of two parts. Part I, the Phase I component of the study, will be conducted at a single center, and will enroll up to 18 patients with histologically documented Stage IV melanoma (per the American Joint Committee on Cancer \[AJCC\] criteria) that is not currently amenable to surgical resection or other therapies. A specified premedication regimen consisting of ranitidine, diphenhydramine, and dexamethasone will be administered to all patients 30 minutes prior to infusion of any dose of KW-2871. Planned doses of KW-2871 are 60 mg/m2, 80 mg/m2, 100 mg/m2 After identification of the MTD, 30 patients will be enrolled at that dose level in Part II of the study. If no MTD is identified after treatment with the 100 mg/m2 dose level, the dose administered in Part II of the study will be 100 mg/m2. If the MTD is determined as 60 mg/m2, this study will be closed to further patient accrual and will not proceed to Part II.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
potentially therapeutic monoclonal antibody for the treatment of advanced stage four melanoma
Comprehensive Cancer Center- University of Alabama at Birmingham
Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
To determine the MTD and a recommended Phase II dose of KW-2871 administered with a specified premedication regimen (rantidine, diphenhydramine, and dexamethasone) in patients with Stage IV melanoma.
Until determination of MTD or recommended dose for evaluation
Time frame: up to 1 year
To characterize the safety and tolerability profile of KW-2871 when administered with a specified premedication regimen.
Time frame: up to 1 year
To obtain a preliminary assessment of antineoplastic activity of KW-2871, as measured by the number of objective antitumor responses, duration of response, time to progression (TTP) and survival in this patient population.
Time frame: up to 1 year
To characterize the pharmacokinetic profile of indicated dose levels of KW-2871 when administered with this specified premedication regimen.
Time frame: up to 1 year
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