Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase 1, Open-Label, Dose-Ranging Study to Assess the Safety and Immunologic Activity of APN401
This phase I trial studies the side effects and best dose of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401) in treating patients with melanoma, kidney, or pancreatic cancer, or other solid tumors that have spread to other parts of the body or that cannot be removed by surgery. There are factors in immune cells in the blood that inhibit their ability to kill cancers. Treating white blood cells with one of these factors in the laboratory may help the white blood cells kill more cancer cells when they are put back in the body.
PRIMARY OBJECTIVES:
I. To determine the toxicities and establish the maximal tolerated dose (MTD) of APN401.
II. To determine the effects of APN401 on immune response.
SECONDARY OBJECTIVES:
I. To document clinical response and survival.
OUTLINE: This is a dose-escalation study.
Patients receive autologous siRNA-transfected peripheral blood mononuclear cells APN401
intravenously (IV) over 30 minutes for 1 course in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually for 1 year.
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