Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma
OBJECTIVES:
Primary
- 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.
Secondary
- 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
tissue.
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
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses
No
Mark R. Albertini, MD
Study Chair
University of Wisconsin, Madison
United States: Federal Government
CDR0000426431
NCT00109863
May 2005
Name | Location |
---|---|
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |