Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma
- Determine the clinical antitumor activity of hu14.18-interleukin-2 fusion protein in
patients with advanced melanoma.
- Determine the duration of response in patients treated with this drug.
- Determine the adverse events in patients treated with this drug.
- Determine the in vivo immunologic activation in patients treated with this drug.
- Determine the induction of anti-hu14.18 and anti-interleukin-2 antibodies in patients
treated with this drug.
- Determine tumor antigen recognition by this drug in select patients with cutaneous
metastatic tumors, as measured by binding of the drug to the cutaneous metastatic tumor
and microscopic changes (including immune cell density and phenotype) of the tumor
OUTLINE: Patients receive hu14.18-interleukin-2 fusion protein IV over 4 hours on days 1-3.
Treatment repeats every 28 days for 2 courses in the absence of symptomatic disease
progression or unacceptable toxicity. Patients then undergo disease reassessment. Patients
with an objective partial or complete clinical response or stable disease receive 2
additional courses of treatment.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-15
Masking: Open Label, Primary Purpose: Treatment
Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses
Mark R. Albertini, MD
University of Wisconsin, Madison
United States: Federal Government
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|