Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

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Brief Title

Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

Official Title

A Phase I, Safety Trial of Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

Brief Summary

      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.
    

Detailed Description

      This is a single center, exploratory pilot safety, open label, phase I trial that will
      evaluate the combination of DC vaccination in 2 groups of patients when combined with
      chemotherapy including FOLFIRINOX and gemcitabine+nab-paclitaxel in patients with pancreatic
      cancer. The investigations will accrue 20 evaluable subjects over 20 months with 10 patients
      in each group. Subjects will be assigned to group 1 or group 2 according to the subject's
      disease stage.

      The protocol will be conducted in two stages:

      The 1st 3 patients will be enrolled to either group to receive DC vaccinations combined with
      standard chemotherapy. A safety analysis will be performed after the first 3 patients have
      completed 6 vaccines. If no vaccine dose-limiting toxicity occurs in any of the 3 patients
      then the study will proceed with stage 2. Stage 2 will include the enrollment of the
      remaining 17 patients.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and feasibility of combining the DC vaccine with chemotherapy DC vaccine dose-limiting toxicities will be measured according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Secondary Outcome

 Objective Response

Condition

Pancreatic Cancer

Intervention

DC Vaccine + Standard of Care Chemotherapy

Study Arms / Comparison Groups

 Group 1
Description:  Group 1 will consist of patients with resectable, borderline resectable or locally advanced pancreatic cancer. Group 1 will receive DC Vaccine + Standard of Care Chemotherapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

7

Start Date

August 2015

Completion Date

April 24, 2017

Primary Completion Date

April 24, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Carlos Becerra, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02548169

Organization ID

015-119


Responsible Party

Sponsor

Study Sponsor

Baylor Research Institute


Study Sponsor

Carlos Becerra, MD, Principal Investigator, Charles A. Sammons Cancer Center/Texas Oncology


Verification Date

January 2019