NCT01727076

Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Carcinoma
• Recurrent Non-Small Cell Lung Carcinoma
• Recurrent Renal Cell Carcinoma
• Recurrent Skin Carcinoma
• Stage III Renal Cell Cancer
• Stage IIIA Cutaneous Melanoma AJCC v7
• Stage IIIA Non-Small Cell Lung Cancer AJCC v7
• Stage IIIB Cutaneous Melanoma AJCC v7
• Stage IIIB Non-Small Cell Lung Cancer AJCC v7
• Stage IIIC Cutaneous Melanoma AJCC v7
• Stage IV Cutaneous Melanoma AJCC v6 and v7
• Stage IV Non-Small Cell Lung Cancer AJCC v7
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
BIOLOGICAL	Recombinant Human Interleukin-15	Given SC

Timeline

• Start date: 2013-02-15
• Primary completion: 2016-06-30
• Completion: 2016-06-30
• First posted: 2012-11-15
• Last updated: 2017-09-15

Locations

5 sites across 1 country: United States