Melanoma (Skin) Clinical Trial
Official title:
Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma
RATIONALE: Biological therapies, such as hu14.18-interleukin-2 fusion protein, may stimulate
the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works
in treating patients 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.
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