Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

Stopped early · Phase 1

Conditions studied: Pancreatic Cancer

In brief

The primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer. The secondary objectives of this trial are to determine preliminary clinical efficacy based on response rates, overall survival and progression free survival compared with historic control, and surgical conversion rate as defined as percent of locally advanced (unresectable) patients achieving resectability within 6 months of treatment initiation. Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune activating events post-vaccination and to correlate clinical response with acquired immune responses.

Key facts

Study ID

NCT02548169

Run by

Baylor Research Institute

People needed

7

Starts

2015-08-01

Expected to finish

2017-04-24

Last updated by the study team

2019-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Suspected pancreatic ductal adenocarcinoma (PDAC) prior to diagnosis or histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology.
• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
• Serum Albumin greater than or equal to 2.0 gm/dL
• Expected survival greater than or equal to 6 months.
• Adequate hematologic function as defined by
• Absolute Neutrophil Count (ANC) greater than 1500/mm\^3
• Platelets greater than or equal to 70,000/mm\^3
• Hemoglobin greater than 9 g/dL
• Adequate liver function, as defined by:
• Serum Total Bilirubin less than or equal to 2 x Upper limit of normal (ULN) mg/dL
• Alanine transaminase (ALT) and Aspartate transaminase (AST) less than or equal to 2.5x Upper limit of normal (ULN)
• Serum Creatinine less than or equal to 2 x Upper limit of normal (ULN) or creatinine clearance greater than or equal to 30 ml/min
• All females of child bearing potential must agree to use contraception to avoid pregnancy throughout the study and for 1 month after the last DC vaccination.
• Subjects must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Subjects may not be consented by a medical power of attorney.
• Subject must be accessible for treatment and follow up.

You may not qualify if…

• History of Organ transplant
• Other malignancy within 5 years, unless the probability of recurrence of the prior malignancy is <5% as determined by the principal investigator.
• Current, active immunosuppressive therapy such as cyclosporine, tacrolimus
• Subjects taking chronic systemic corticosteroid therapy for any reason are not eligible. Subjects may receive steroids as prophylactic anti-emetics, not toe exceed 10mg Decadron weekly. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require chronic systemic corticosteroids after beginning vaccination will be removed from the study.
• Significant or uncontrolled congestive heart failure, myocardial infarction or significant ventricular arrhythmias within the last 6 months
• Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever
• Autoimmune disease ( e.g. systemic lupus erythematosis, rheumatoid arthritis). Subjects with remote history of asthma or mild active asthma are eligible.
• Other severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
• Severe impaired lung functions as defined by spirometry and diffusing capacity of lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
• Uncontrolled diabetes as defined by fasting serum glucose >250 mg/dL
• Live disease such as cirrhosis or severe hepatic impairment (child pugh class C)
• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or quality of the data.
• Other investigational or anti-cancer treatments while participating in this study.
• Other active cancer
• Women who are pregnant or breastfeeding
• Known to be HIV positive

Where it is running

• Charles A. Sammons Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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