This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To determine the toxicities and establish the safety of multiple infusions of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401). SECONDARY OBJECTIVES: I. To determine the immunologic effects of multiple infusions of APN401. II. To document clinical response and survival. OUTLINE: Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Correlative studies
Given IV
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0
Will be categorized by organ system and severity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Related treatment emergent adverse events by maximum severity. Unexpected grade 4 and all grade 5 events are considered severe adverse events. CTCAE grades 3-5 allergic reactions related to study cell infusion CTCAE grades 3 and greater autoimmune reactions other than that vitiligo CTCAE grades 3 and greater organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary or neurologic) not pre-existing or due to the underlying malignancy and occurring within 30 days of study product infusion
Time frame: Up to 1 year
Clinical Response as Assessed by RECIST
Will be summarized as frequency counts and percentages. RECIST criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Time frame: Up to approximately 4 years
Frequency of Immune Cells
Immune response as measured by frequency of immune cells
Time frame: Days 15 and 28
Immune Response as Measured by Interferon Production
Immune response as measured by interferon production
Time frame: Days 15 and 28
Neutrophil to Lymphocyte Ratio
Immune response as measured by neutrophil to lymphocyte ratio
Time frame: Days 15 and 28
Overall Survival (OS)
Exploratory survival plots will be estimated using the Kaplan Meier approach and median overall survival will be estimated if enough events occur.
Time frame: From the initial infusion to confirmation of death, assessed up to approximately 4 years
Progression-free Survival (PFS)
Exploratory survival plots will be estimated using the Kaplan Meier approach and median PFS will be estimated if enough events occur.
Time frame: From the initial infusion to confirmation of progression or death, assessed up to approximately 4 years
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