Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase 1 Study of Recombinant Human IL15 (rhIL15) in Adults With Advanced Solid Tumors: Melanoma, Renal Cell, Non-Small Cell Lung and Squamous Cell Head and Neck Cancer
This phase I trial studies the side effects and best dose of recombinant interleukin-15 in treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made naturally in the body and when made in the laboratory may help stimulate the immune system in different ways and stop tumor cells from growing.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of recombinant human IL15 (rhIL15)
administered subcutaneously.
SECONDARY OBJECTIVES:
I. To determine the effect of the dose schedules of rhIL15 on the number and phenotype of
peripheral blood mononuclear cells including: total white blood cell count; absolute
lymphocyte count (ALC); and total number of T cells and natural killer (NK) cells, as well as
activated T cells, T cell subsets and NK cell subsets.
II. To determine the effects of the dose schedules of rhIL15 on the function of peripheral
blood mononuclear cells including: T cell subset response to recall viral antigens including
cytomegalovirus (CMV) and influenza A virus; T cell responses to non-physiologic stimuli
including: phytohemagglutinin (PHA); and NK cell cytokine (interferon gamma [IFN-y])
secretion and degranulation by cluster of differentiation 107a (CD107a) expression.
III. To assess tumor response rate by objective response rate (ORR). IV. To assess the
immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of National Cancer
Institute (NCI) rhIL15.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant interleukin-15 subcutaneously (SC) daily on days 1-5 of weeks 1
and 2. Treatment repeats every 28 days (4 weeks) for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 24 weeks.
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