The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process. An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.
M.D. Anderson Cancer Institute
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Maximum tolerated dose
Time frame: one year
Tumor response
Time frame: one year
Cachexia Response
Change in LBT as measured by DEXA
Time frame: 8 weeks
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